The Australian Immunisation Handbook 10th Edition 2013

The Australian 

Immunisation Handbook 

10th Edition 2013 

i MMUNi SATi ON

Copyright 

The Australian Immunisation Handbook 10th edition 2013 

ISBN: 978-1-74241-861-2 

Online ISBN: 978-1-74241-862-9 

Publications approval number: D0903 

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© Commonwealth of Australia 2013 

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© Commonwealth of Australia 2013 

This work is copyright. You may download, display, print and reproduce the whole or 

part of this work in unaltered form for your own personal use or, if you are part of an 

organisation, for internal use within your organisation, but only if you or your organisation 

do not use the reproduction for any commercial purpose and retain this copyright notice 

and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted 

by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved 

and you are not allowed to reproduce the whole or any part of this work in any way 

(electronic or otherwise) without first being given the specific written permission from the 

Commonwealth to do so. Requests and inquiries concerning reproduction and rights are 

to be sent to the Online, Services and External Relations Branch, Department of Health and 

Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au. 

These guidelines were approved by the Chief Executive Officer of the National Health and 

Medical Research Council (NHMRC) on 25/01/2013, under Section 14A of the National Health and 

Medical Research Council Act 1992. In approving these guidelines the NHMRC considers that they 

meet the NHMRC standard for clinical practice guidelines. This approval is valid for a period of 

five years. 

NHMRC is satisfied that they are based on the systematic identification and synthesis of the 

best available scientific evidence and make clear recommendations for health professionals 

practising in an Australian health care setting. The NHMRC expects that all guidelines will be 

reviewed no less than once every five years. 

This publication reflects the views of the authors and not necessarily the views of the 

Australian Government. 

ii The Australian Immunisation Handbook 10th edition

FOREWORD 

Since 1932, when Government vaccination began for Australian children, illness 

and death from vaccine-preventable diseases have fallen greatly. Australia still has 

one of the world’s most comprehensive publicly funded immunisation programs. 

As a result, tetanus, diphtheria, Haemophilus influenzae type b, poliomyelitis, 

congenital rubella and newly acquired hepatitis B are no longer seen or are 

extremely rare. 

Immunisation is still the safest and most effective way to protect Australians from 

vaccine-preventable disease. The Government is working towards increasing child 

immunisation rates over time by giving parents stronger incentives to have their 

children fully immunised. 

The Australian Immunisation Handbook, approved by the National Health and 

Medical Research Council (NHMRC), includes clinical information for Australian 

immunisation providers on the safest and most effective use of vaccines, new 

vaccines and vaccine-preventable diseases in Australia. It is also a valuable tool to 

help immunisation providers explain the benefits of immunisation to their patients. 

I’m confident that with your ongoing commitment, immunisation coverage rates 

will keep on improving. We need immunisation providers to take every available 

opportunity to appropriately vaccinate children and adults. We also need herd 

immunity to keep on growing, so that the risk of exposure to vaccine-preventable 

diseases such as pertussis and measles is minimised as far as possible. 

This Handbook includes information on changes to the National Immunisation 

Program. This includes, for example, the recent extension of the 

Human Papillomavirus (HPV) Vaccination Program to include males aged 

12–13 years. Already the HPV vaccine has had an impact, significantly reducing the 

number of lesions that lead to cervical cancer amongst women in the vaccinated 

age group. Providing the HPV vaccine to boys will protect them and increase the 

effectiveness of the vaccination program for girls. 

By building on Australia’s world-class immunisation program, we are stopping 

vaccine-preventable diseases and that makes a difference to the quality of life for 

Australian families. 

Finally, I would like to thank the Chair, Professor Terry Nolan, and members 

of the Australian Technical Advisory Group on Immunisation, its working 

parties, technical writers and advisors for their work in producing this excellent 

resource. It will be a great help to everyone involved in supporting and delivering 

immunisation services in Australia. 

The Hon Tanya Plibersek MP 

Minister for Health 

iii

iv The Australian Immunisation Handbook 10th edition

TABLE OF CONTENTS 

PART 1 INTRODUCTION TO THE AUSTRALIAN IMMUNISATION HANDBOOK 1 

1.1 Background 1 

1.2 Development of the 10th edition of the Handbook 3 

1.3 How to use the 10th edition Handbook 5 

1.4 What’s new 7 

1.5 Fundamentals of immunisation 18 

PART 2 VACCINATION PROCEDURES 24 

2.1 Pre-vaccination 24 

2.2 Administration of vaccines 65 

2.3 Post-vaccination 85 

PART 3 VACCINATION FOR SPECIAL RISK GROUPS 104 

3.1 Vaccination for Aboriginal and Torres Strait Islander people 104 

3.2 Vaccination for international travel 113 

3.3 Groups with special vaccination requirements 130 

PART 4 VACCINE-PREVENTABLE DISEASES 176 

4.1 Cholera 176 

4.2 Diphtheria 182 

4.3 Haemophilus influenzae type b 191 

4.4 Hepatitis A 198 

4.5 Hepatitis B 208 

4.6 Human papillomavirus 231 

4.7 Influenza 243 

4.8 Japanese encephalitis 259 

4.9 Measles 267 

4.10 Meningococcal disease 283 

4.11 Mumps 295 

4.12 Pertussis 302 

4.13 Pneumococcal disease 317 

4.14 Poliomyelitis 338 

4.15 Q fever 345 

4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus) 353 

v

4.17 Rotavirus 372 

4.18 Rubella 384 

4.19 Tetanus 397 

4.20 Tuberculosis 408 

4.21 Typhoid 416 

4.22 Varicella 423 

4.23 Yellow fever 439 

4.24 Zoster (herpes zoster) 446 

PART 5 PASSIVE IMMUNISATION 456 

5.1 Passive immunisation using immunoglobulin preparations 456 

APPENDICES 465 

APPENDIX 1: Contact details for Australian, state and territory government 

health authorities and communicable disease control 465 

APPENDIX 2: Literature search strategy for the 10th edition of the Handbook 467 

APPENDIX 3: Components of vaccines used in the National 

Immunisation Program 469 

APPENDIX 4: Commonly asked questions about vaccination 473 

A.4.1 General questions 473 

A4.2 Questions about contraindications and precautions 477 

A4.3 Questions about vaccine safety 481 

A4.4 Questions about vaccine content 484 

A4.5 Questions about the need for immunisation 487 

A4.6 Further information about vaccination 488 

APPENDIX 5: Glossary of technical terms 489 

APPENDIX 6: Commonly used abbreviations 495 

APPENDIX 7: Overview of vaccine availability in Australia 498 

INDEX 500 

vi The Australian Immunisation Handbook 10th edition

LIST OF TABLES 

Table 2.1.1: Pre-vaccination screening checklist 30 

Table 2.1.2: Responses to relevant conditions or circumstances identified 

through the pre-vaccination screening checklist 31 

Table 2.1.3: Live attenuated parenteral and oral vaccines 37 

Table 2.1.4: False contraindications to vaccination 38 

Table 2.1.5: Minimum acceptable age for the 1st dose of scheduled vaccines 

in infants in special circumstances 46 

Table 2.1.6: Number of vaccine doses that should have been administered 

by the current age of the child 49 

Table 2.1.7: Minimum acceptable dose intervals for children

Table 3.1.1: Additional vaccines recommended for Indigenous persons, 

due to their higher risk of disease 105 

Table 3.2.1: Dose and routes of administration of commonly used vaccines 

in adult travellers 123 

Table 3.2.2: Recommended lower age limits of travel vaccines for children 127 

Table 3.3.1: Recommendations for vaccination in pregnancy 135 

Table 3.3.2: Recommendations for vaccinations for solid organ transplant 

(SOT) recipients 151 

Table 3.3.3: Recommendations for revaccination following haematopoietic 

stem cell transplant (HSCT) in children and adults, irrespective 

of previous immunisation history 156 

Table 3.3.4: Categories of immunocompromise in HIV-infected persons, based 

on age-specific CD4 + counts and percentage of total lymphocytes 158 

Table 3.3.5: Recommendations for vaccination in persons with functional or 

anatomical asplenia 163 

Table 3.3.6: Recommended intervals between either immunoglobulins or 

blood products and measles-mumps-rubella (MMR), measlesmumps-rubella-varicella 

(MMRV) or varicella vaccination 167 

Table 3.3.7: Recommended vaccinations for persons at increased risk of 

certain occupationally acquired vaccine-preventable diseases 170 

Table 4.4.1: Recommended doses and schedules for use of inactivated 

hepatitis A and hepatitis A combination vaccines 202 

Table 4.5.1: Recommended schedules for use of monovalent hepatitis B and 

hepatitis B combination vaccines 214 

Table 4.5.2: Accelerated hepatitis B vaccination schedules (for persons 

with imminent risk of exposure) 216 

Table 4.5.3: Post-exposure prophylaxis for non-immune persons exposed 

to a HBsAg-positive source 229 

Table 4.7.1: Recommended doses of influenza vaccine 251 

Table 4.9.1: Recommendations for measles vaccination with (a) measlesmumps-rubella 

(MMR) (currently available), and (b) once 

measles-mumps-rubella-varicella (MMRV) vaccines are available 

from July 2013 273 

Table 4.9.2: Post-exposure prophylaxis ≤72 hours since exposed to measles 

for non-immune individuals (adapted from Measles: national 

guidelines for public health units) 281 

Table 4.13.1: Recommendations for pneumococcal vaccination for children 

aged

List 4.13.1: Conditions associated with an increased risk of invasive 

pneumococcal disease (IPD) in children and adults, by severity 

of risk 326 


aged 2–5 years with a medical condition(s) associated with an 

increased risk of invasive pneumococcal disease (IPD) 328 

Table 4.13.3: Recommendations for pneumococcal vaccination using 23vPPV 

for adults who do not have a condition(s) associated with an 

increased risk of invasive pneumococcal disease (IPD) 332 

Table 4.15.1: Interpretation and action for serological and skin test results 

(with modifications from A guide to Q fever and Q fever vaccination 

(CSL Biotherapies, 2009)) 350 

Table 4.16.1: Lyssavirus exposure categories 360 

Table 4.16.2: Post-exposure prophylaxis commenced overseas and 

recommended completion in Australia 365 

Table 4.17.1: Upper age limits for dosing of oral rotavirus vaccines 378 

Table 4.19.1: Guide to tetanus prophylaxis in wound management 404 

Table 4.22.1: Recommendations for varicella vaccination with (a) monovalent 

varicella vaccine (VV) (currently available), and (b) once measlesmumps-rubella-varicella 

(MMRV) vaccines are available from 

July 2013 428 

Table 4.22.2: Zoster immunoglobulin-VF (ZIG) dose based on weight 436 

Table A2.1: Electronic databases searched for the 10th edition 467 

Table A3.1: Components of vaccines used in the National 

Immunisation Program 469 

Table A7.1: Key dates when vaccines first came into widespread 

use in Australia 498 

ix

LIST OF FIGURES 

Figure 2.1.1: Catch-up worksheet for children

PREFACE 

The 10th edition of The Australian Immunisation Handbook was prepared by 

the Australian Technical Advisory Group on Immunisation of the Australian 

Government Department of Health and Ageing. 

Members of the Australian Technical Advisory Group on 

Immunisation 

Chair 

Professor Terry Nolan, Paediatrician; Epidemiologist and Head, School of 

Population Health, The University of Melbourne, Victoria 

Deputy Chair 

Associate Professor Peter Richmond, School of Paediatrics and Child Health, 

The University of Western Australia; General Paediatrician and Paediatric 

Immunologist, Princess Margaret Hospital for Children, Western Australia 

Voting and ex-officio members 

Associate Professor Ross Andrews, Menzies School of Health Research, 

Northern Territory 

Associate Professor Christopher Blyth, School of Paediatrics and Child Health, 

Faculty of Medicine, Dentistry and Health Sciences, The University of Western 

Australia, Princess Margaret Hospital, Western Australia (member from July 2012) 

Ms Sue Campbell-Lloyd, Manager, Immunisation Unit, AIDS/Infectious Diseases 

Branch, NSW Health, New South Wales (member until June 2012) 

Dr Grahame Dickson, Medical Officer, Drug Safety and Evaluation Branch, 

Therapeutic Goods Administration, Australian Government Department of 

Health and Ageing, Australian Capital Territory (member until August 2012) 

Dr Nicole Gilroy, Infectious Diseases consultant, St Vincent’s Hospital, Sydney; 

Blood Marrow Transplant (BMT) Network, New South Wales 

Ms Madeline Hall, Public Health Nurse, Queensland Health, Queensland 

(member from July 2012) 

Clinical Professor David Isaacs, Senior Staff Specialist, Department of Infectious 

Diseases and Microbiology, The Children’s Hospital at Westmead and Paediatric 

Infectious Diseases, The University of Sydney, New South Wales 

Dr Rosemary Lester, Chief Health Officer, Department of Health, Victoria 

(member until December 2011) 

xi

Dr Ting Lu, Medical Officer, Office of Medicines Authorisation, Market 

Authorisation Group, Therapeutic Goods Administration, Australian 

Government Department of Health and Ageing, Australian Capital Territory 

(member from September 2012) 

Professor Peter McIntyre, Professor of Paediatrics and Preventive Medicine, 

The University of Sydney; Director, National Centre for Immunisation Research 

and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at 

Westmead, New South Wales 

Associate Professor Jodie McVernon, School of Population Health, The University 

of Melbourne, Victoria (member from January 2012) 

Dr Joanne Molloy, General Practitioner, GP Association of Geelong, Victoria 

Ms Stephanie Newell, Consumer representative (member until June 2012) 

Associate Professor Michael Nissen, Director of Infectious Diseases and 

Clinical Microbiologist, Unit Head of Queensland Paediatric Infectious Disease 

Laboratory; Associate Professor in Biomolecular, Biomedical Science and Health, 

Royal Children’s Hospital, Queensland (member until June 2012) 

Dr Rod Pearce, General Practitioner, Medical Officer of Health, Eastern Health 

Authority, Adelaide; GP Immunisation Advisor, Adelaide Central and Eastern 

Division of General Practice, South Australia (member until June 2012) 

Ms Karen Peterson, Immunisation Manager, Queensland Health, Queensland 

(member from July 2012) 

Ms Debra Petrys, Consumer representative (member from July 2012) 

Ms Helen Pitcher, Public Health Nurse, Department of Human Services, Victoria 

(member until June 2012) 

Ms Julianne Quaine, Assistant Secretary, Health Protection Programs Branch, 

Office of Health Protection, Australian Government Department of Health and 

Ageing, Australian Capital Territory 

Dr Greg Rowles, General Practitioner, Riddells Creek, Victoria (member from 

July 2012) 

Dr Christine Selvey, Communicable Diseases Network Australia, Queensland 

Health, Queensland (member from January 2012) 

Professor Steven Wesselingh, Executive Director, South Australian Health and 

Medical Research Institute, South Australia (member from July 2012) 

Secretary 

Ms Monica Johns, Director, Immunisation Policy Section, Immunisation Branch, 

Office of Health Protection, Australian Government Department of Health and 

Ageing, Australian Capital Territory 

xii The Australian Immunisation Handbook 10th edition

Secretariat support, Australian Technical Advisory Group on 


Ms Sandy Anderson; Ms Jessica Hutchison 

Senior technical editor 

Associate Professor Kristine Macartney, Deputy Director Government Programs, 

National Centre for Immunisation Research and Surveillance of Vaccine 

Preventable Diseases, The Children’s Hospital at Westmead; Discipline of 

Paediatrics and Child Health, The University of Sydney 

Technical editor 

Dr Jane Jelfs, Manager Policy Support, National Centre for Immunisation 

Research and Surveillance of Vaccine Preventable Diseases 

Assistant technical editor 

Dr Melina Georgousakis, Research Officer, National Centre for Immunisation 


Senior technical writer 

Dr Clayton Chiu, Public Health Physician, National Centre for Immunisation 


Technical writers 

Mr Brett Archer; Ms Kathryn Cannings; Dr Bradley Christian; Dr Nigel 

Crawford; Dr Aditi Dey; Dr Anita Heywood; Dr Sanjay Jayasinghe; Dr Robert 

Menzies; Dr Helen Quinn; Dr Tom Snelling; Ms Kirsten Ward; Dr Nicholas Wood 

Editorial support 

Ms Donna Armstrong, Editing and Publications Officer, National Centre for 

Immunisation Research and Surveillance of Vaccine Preventable Diseases 

Library support 

Ms Catherine King, Information Manager, National Centre for Immunisation 


Mr Edward Jacyna, Assistant Librarian, National Centre for Immunisation 


Administration support 

Ms Lyn Benfield, Senior Administration Project Officer, National Centre for 

Immunisation Research and Surveillance of Vaccine Preventable Diseases 

xiii

Acknowledgments 

Dr Frank Beard 

Professor Julie Bines 

Dr Julia Brotherton 

Associate Professor Tony Brown 

Professor Margaret Burgess 

Dr Dave Burgner 

Dr Jim Buttery 

Professor Jonathan Carapetis 

Dr Ben Cowie 

Dr Andrew Daley 

Professor Basil Donovan 

Dr Mark Douglas 

Professor David Durrheim 

Professor Dominic Dwyer 

Professor Joan Faoagali 

Dr Tony Gherardin 

Dr Heather Gidding 

Professor Lyn Gilbert 

Dr Robert Hall 

Dr Alan Hampson 

Dr Penny Hutchinson 

Dr Heath Kelly 

Professor Michael Kidd 

Dr Ann Koehler 

xiv The Australian Immunisation Handbook 10th edition 

Dr Vicki Krause 

Associate Professor Stephen Lambert 

Associate Professor Amanda Leach 

Professor Raina MacIntyre 

Professor John Mackenzie 

Associate Professor Guy Marks 

Dr Jeremy McAnulty 

Dr Brad McCall 

Dr Elizabeth McCarthy 

Dr Neil Parker 

Professor Bill Rawlinson 

Associate Professor Tilman Ruff 

Dr Rosalie Schultz 

Dr Vicky Sheppeard 

Associate Professor Vitali Sintchenko 

Associate Professor Monica Slavin 

Associate Professor David Smith 

Dr Bruce Thorley 

Dr Joe Torressi 

Dr Siranda Torvaldsen 

Ms Maureen Watson 

Dr Rosalind Webby 

Dr Melanie Wong 

Professor Nick Zwar

PART 1 INTRODUCTION TO THE AUSTRALIAN 

IMMUNISATION HANDBOOK 

1.1 BACKGROUND 

For more than 200 years, since Edward Jenner first demonstrated that 

vaccination offered protection against smallpox, the use of vaccines has 

continued to reduce the burden of many infectious diseases. Vaccination has 

been demonstrated to be one of the most effective and cost-effective public 

health interventions. Worldwide, it has been estimated that immunisation 

programs prevent approximately 2.5 million deaths each year. 1 The global 

eradication of smallpox in 1997, near elimination of poliomyelitis and global 

reduction in other vaccine-preventable diseases, are model examples of disease 

control through immunisation. 

Vaccination not only protects individuals, but also protects others in the 

community by increasing the overall level of immunity in the population 

and thus minimising the spread of infection. This concept is known as ‘herd 

immunity’. It is vital that healthcare professionals take every available 

opportunity to vaccinate children and adults. Australia has one of the most 

comprehensive publicly funded immunisation programs in the world. As a result 

of successful vaccination programs in Australia, many diseases, for example, 

tetanus, diphtheria, Haemophilus influenzae type b and poliomyelitis, do not occur 

now or are extremely rare in Australia. 2 

The purpose of The Australian Immunisation Handbook is to provide clinical 

guidelines for health professionals on the safest and most effective use of vaccines 

in their practice. These recommendations are developed by the Australian 

Technical Advisory Group on Immunisation (ATAGI) and were considered 

for approval by the National Health and Medical Research Council (NHMRC) 

(under section 14A of the NHMRC Act 1992). 

The Handbook provides guidance based on the best scientific evidence available 

at the time of publication from published and unpublished literature. Further 

details regarding the Handbook revision procedures are described below in 1.2 

Development of the 10th edition of the Handbook. The reference lists for all chapters 

are included in the electronic version of the Handbook, which is available via the 

Immunise Australia website (www.immunise.health.gov.au). 

The information contained within this Handbook was correct as at October 2012. 

However, the content of the Handbook is reviewed regularly. The 10th edition 

of The Australian Immunisation Handbook will remain current unless amended 

electronically via the Immunise Australia website or until the 11th edition of the 

Handbook is published. 


1.1 BACKGROUND

Information is provided in the Handbook for all vaccines that are available in 

Australia at or near the time of publication. These include many vaccines that are 

funded under the National Immunisation Program (NIP). A copy of the current 

NIP schedule is provided with the hard copy of the Handbook. However, the 

NIP schedule may also be updated regularly; immunisation service providers 

should consult the Immunise Australia website (www.immunise.health.gov. 

au) for changes. A number of vaccines included in this Handbook are not part 

of the routine immunisation schedule; these vaccines may be given to, for 

example, persons travelling overseas, persons with a medical condition placing 

them at increased risk of contracting a vaccine-preventable disease, or those at 

occupational risk of disease. 

Electronic updates to the 10th edition of 

The Australian Immunisation Handbook will be available at: 

www.immunise.health.gov.au 

References 

A full reference list is available on the electronic Handbook or website 


2 The Australian Immunisation Handbook 10th edition

1.2 DEVELOPMENT OF THE 10TH EDITION OF THE HANDBOOK 

The 10th edition of the Handbook has been developed by the Australian Technical 

Advisory Group on Immunisation (ATAGI), which provides advice to the Federal 

Minister for Health on the Immunise Australia Program and other vaccinerelated 

issues. In addition to technical experts from many fields, the ATAGI’s 

membership includes a consumer representative and general practitioners. Staff 

of the National Centre for Immunisation Research and Surveillance of Vaccine 

Preventable Diseases (NCIRS) provided the technical support to the ATAGI to 

develop the Handbook. 

It is important to note that recommendations contained within the Handbook 

do not formally address the cost-effectiveness of different vaccines or different 

vaccine schedules. Since January 2006, the cost-effectiveness of vaccines 

is assessed by the Pharmaceutical Benefits Advisory Committee (PBAC), 

which advises government on the funding of vaccines under the National 

Immunisation Program and/or Pharmaceutical Benefits Scheme (PBS). Most, 

but not all, of the recommendations made within the Handbook will be funded 

under the NIP, PBS or via other means, such as through special schemes and 

state- or territory-based programs. 

1.2.1 Process of developing Handbook recommendations 

The Handbook is designed as a general guide to inform clinicians on the safest and 

most effective vaccination strategies, using the highest quality evidence available. 

In the absence of high-quality evidence, such as well-conducted randomised 

controlled trials and meta-analyses, the ATAGI based its recommendations on 

less rigorous studies, such as uncontrolled clinical trials, case-series and/or other 

observational studies. Where clinical guidelines were available on specific topics, 

these were also consulted to help frame recommendations, if relevant, in the 

Australian setting. Further details on literature search strategies utilised for the 

production of this edition can be found in Appendix 2. The ATAGI also consulted 

immunisation handbooks produced by comparable countries. When published 

sources were inadequate, recommendations were based on expert opinion. 

However, limitations and challenges to developing recommendations continue to 

exist when there are unaddressed scientific questions, complex medical practice 

issues and continuous new information, as well as differences in expert opinion. 

Despite these limitations, the ATAGI has sought to provide clear and relevant 

recommendations wherever possible. 

The 1st edition of The Australian Immunisation Handbook was published in 1975. 

Due to its longevity, scope and complexity, the Handbook does differ from other 

NHMRC guidelines. As such, recommendations contained in the Handbook do 

not contain formal levels or grades of evidence or evidence tables. The grades of 

evidence assigned to recommendations for the three newly vaccine-preventable 

diseases (human papillomavirus [HPV], rotavirus and herpes zoster) that were 

included in the 9th edition Handbook (and its electronic amendments) have now 


1.2 DEVELOPMENT OF THE 10TH OF EDITION THE 10TH OF THE HANDBOOK 

EDITION OF THE HANDBOOK

een removed and replaced with an evidence statement for consistency with 

other chapters in the 10th edition of the Handbook. The ATAGI has developed new 

recommendations for the Handbook after considering clinical questions, reviewing 

available evidence, as described above, and through extensive consultation with 

other experts (described below). Evidence statements for recommendations, with 

cross reference to other relevant sections of the Handbook, have been included 

wherever possible. 

1.2.2 Consultation and input into the draft 10th edition Handbook 

Prior to completion of the draft 10th edition Handbook, the ATAGI sought expert 

review of individual chapters by leading Australian experts. These reviewers, 

who are acknowledged in the front of this Handbook, provided input to further 

refine each chapter. The ATAGI also, where relevant, consulted members of 

each of its current disease-based Working Parties. Other peak advisory groups, 

in particular the National Immunisation Committee, were also consulted and 

provided valuable input into the development of this revised edition. The draft 

10th edition of the Handbook was available for public consultation over a 4-week 

period during July–August 2012. The ATAGI reviewed all public comments 

received and, where necessary, incorporated these as changes to the Handbook. 

The NHMRC was also consulted throughout the development of the 10th 

edition of the Handbook, prior to the Handbook being proposed for submission to 

the NHMRC for consideration of approval (under section 14A of the NHMRC 

Act 1992). 

1.2.3 Implementation of recommendations in the 10th edition 

Handbook 

The 10th edition of the Handbook is disseminated directly to all registered 

medical practitioners in Australia. Additional hard copies are distributed to 

other immunisation service providers via their state or territory health authority. 

An electronic version of the Handbook is freely accessible on the Immunise 

Australia Program website (www.immunise.health.gov.au). Implementation of 

the recommendations as stated in the Handbook is undertaken by immunisation 

service providers in conjunction with their state or territory health authority and 

the Immunise Australia Program of the Australian Government Department of 

Health and Ageing. 


1.3 HOW TO USE THE 10TH EDITION HANDBOOK 

The following information provides an overview of how information is presented 

in this 10th edition of The Australian Immunisation Handbook, to guide the reader 

in how to best use this resource. 

The Handbook is divided into five major parts. Part 1 contains information on 

the development process for the Handbook, a summary of changes from the 9th 

edition Handbook, and an overview of the general principles of immunisation, 

including both active and passive immunisation, vaccine efficacy and vaccine 

safety. Part 2 of the Handbook is divided into three chapters, which describe 

the processes and procedures involved around a vaccination encounter: prevaccination 

requirements; a detailed discussion of the administration of vaccines; 

and information on post-vaccination considerations. In Part 3 of the Handbook, 

there are three chapters, each dedicated to vaccinations for different special risk 

groups, including Aboriginal and Torres Strait Islander people, international 

travellers, and other special risk categories (e.g. immunocompromised persons, 

pregnant women and others). 

Part 4 of the Handbook contains 24 chapters, each dealing with an individual 

disease for which a vaccine, or vaccines, are currently available in Australia. 

These chapters all follow the same format and are divided into various sections 

describing: 

• the biology, clinical features and epidemiology of the disease 

• information on vaccines, with those available, or soon to be available, in 

Australia highlighted in a shaded box (for more information see also the 

Therapeutic Goods Administration, www.tga.gov.au, for the latest vaccine 

product information document provided by the manufacturer and 

1.5.3 Active immunisation) 

• recommendations for vaccine use 

• use in pregnancy and breastfeeding 

• contraindications, precautions and advice on adverse events following 

immunisation specific to the vaccine(s) (for more information see 

1.5.5 Vaccine safety and adverse events following immunisation) 

• information on the public health management of each disease; this is 

only given in detail where there are specific additional recommendations 

for vaccine use in the context of disease control and/or post-exposure 

prophylaxis 

• variations from product information. 


1.3 HOW TO USE THE 

10TH EDITION HANDBOOK

Variations from product information 

In some instances, the ATAGI recommendations in the Handbook 

may differ from information provided by the manufacturer in the 

vaccine product information document (PI); these differences may be 

recommendations that are in addition to or instead of those listed in the 

PI. Where indicated, variations from the PI are detailed in each relevant 

vaccine chapter under the heading ‘Variations from product information’. 

Where a variation exists, the ATAGI recommendation should be 

considered best practice. 

The reader is encouraged to seek additional information on communicable 

disease surveillance, prevention and control, including published guidelines, 

from the Communicable Diseases Network Australia (CDNA) via the Australian 

Government CDNA website (www.health.gov.au/cdnasongs). 

Part 5 of the Handbook pertains to passive immunisation using immunoglobulin 

preparations and provides an overview of the available products and their 

intended use. 

There are a number of appendices, including contact details for state and 

territory health departments (Appendix 1); the literature search strategies 

used for the 10th edition of the Handbook (Appendix 2); components used in 

the vaccines available via the National Immunisation Program (Appendix 3); 

some commonly asked questions (Appendix 4); a glossary of terms used in the 

Handbook (Appendix 5); abbreviations used in the Handbook (Appendix 6); and a 

list of dates when various vaccines became available in Australia (Appendix 7). 


1.4 WHAT’S NEW 

All chapters have been updated and revised, where necessary, from the 9th 

edition. The 10th edition introduces new vaccines, changes to the schedules and 

recommendations, and changes to the presentation of the Handbook. 

1.4.1 New chapters and chapters that no longer appear in 

the Handbook 

• Layout of the Handbook differs from the previous edition. The Handbook 

is now in 5 parts: Part 1 Introduction to The Australian Immunisation 

Handbook; Part 2 Vaccination procedures; Part 3 Vaccination for special risk 

groups; Part 4 Vaccine-preventable diseases; and Part 5 Passive immunisation. 

• Part 1 now includes the development process for the Handbook 

(previously in Appendix 2) and information on the fundamentals of 

immunisation, including passive and active immunisation, vaccine 

efficacy and vaccine safety. 

• The new Part 5 Passive immunisation contains information previously 

contained in Chapter 3.8 of the 9th edition, Immunoglobulin preparations. 

• The chapter on Australian bat lyssavirus and rabies is now listed under Rabies 

and other lyssaviruses (including Australian bat lyssavirus) in the alphabetical list 

of diseases in Part 4. 

• The chapter on zoster (herpes zoster) is now included as a disease chapter 

in Part 4 in this printed version of the 10th edition. It had previously been 

available as an online update to the 9th edition. 

• The chapter on smallpox has been deleted. For information on smallpox, 

please go to the Australian Government website www.health.gov.au and 

use the index option to select the smallpox fact sheet. 

• Some appendices contained in the 9th edition have been deleted: 

» Products registered in Australia but not currently available (previously 

Appendix 3); information regarding such products can be sought from 

the Therapeutic Goods Administration (www.tga.gov.au) 

» Definitions of adverse events following immunisation (previously Appendix 6); 

some common adverse events are now defined in the glossary of technical 

terms and an expanded section on adverse events following immunisation 

is now provided in Part 2 (2.3.2) 

» Summary table – procedures for a vaccination encounter (previously Appendix 10); 

this information is now incorporated throughout Part 2. 

1.4.2 Changes to the format of disease chapters in Part 4 

• Where relevant, information on reconstitution and stability of reconstituted 

vaccines has been included in the ‘Transport, storage and handling’ section of 

disease chapters. 


1.4 WHAT'S NEW

• Where relevant, information on co-administration with other vaccines 

and interchangeability of vaccines is now included in the ‘Dosage and 

administration’ section of disease chapters. 

• A ‘Pregnancy and breastfeeding’ section has been added to all disease 

chapters. 

• Information on the public health management of each disease is only given 

in detail where there are specific additional recommendations for vaccine 

use in the context of disease control and/or post-exposure prophylaxis. 

The reader is referred to published guidelines from the Communicable 

Diseases Network Australia (CDNA), where available. 

• The Evidence Grades assigned in the 9th edition to recommendations 

contained within three chapters – Human papillomavirus, Rotavirus and Zoster 

(online only) – have been removed (see discussion in 1.2 Development of the 

10th edition of the Handbook regarding Handbook development). 

1.4.3 Overview of major changes to recommendations 

The following list summarises major changes to recommendations and other 

important information that have occurred in each part of the 10th edition of 

the Handbook. 

Part 2 Vaccination procedures 

2.1 Pre-vaccination 

• The checklist summarising activities required for optimal storage of vaccines 

has been deleted; readers are referred to the National vaccine storage guidelines: 

Strive for 5. 

• The table (Table 2.1.5) containing information on the minimum acceptable 

age for the 1st vaccine doses in infants now provides advice on action 

required in case of early administration. 

• Catch-up recommendations and tables are now for children aged

2.2 Administration of vaccines 

• Advice is now provided on the use of vaccines in multi-dose vials. 

• Advice is provided on what to do if a vaccine is inadvertently administered 

via a route (e.g. intramuscular [IM] or subcutaneous [SC]) other than for 

which it is recommended. 

• Information is now provided on vaccinating children with congenital limb 

malformation, children in spica casts, patients undergoing treatment for 

breast cancer, and patients with lymphoedema. 

• The section on administration of multiple vaccine injections at the same visit 

now includes advice on the order in which to give sequential vaccines and 

advice on simultaneous injections by two providers. 

2.3 Post-vaccination 

• The section on adverse events following immunisation has been enhanced 

and expanded, including use of adrenaline autoinjectors for anaphylaxis 

treatment and more information on reporting of adverse events following 

immunisation. 

• Contact details are provided for obtaining HPV vaccination history from 

the National HPV Vaccination Program Register (NHVPR, or the ‘HPV 

Register’). 

• The section on documentation of vaccination has been expanded to include 

updated details for reporting to the ACIR, and information on the National 

HPV Vaccination Program Register and other registers. 

Part 3 Vaccination for special risk groups 

3.1 Vaccination for Aboriginal and Torres Strait Islander people 

• Information on the burden of influenza in Indigenous children, and the 

rationale for vaccination of those, especially ≥6 months to

3.2 Vaccination for international travel 

• This section has been updated and expanded and information on 

recommended vaccines is now divided into routinely recommended vaccines 

(that are not specifically related to travelling overseas) and selected vaccines 

that are recommended based on travel itinerary, activities and likely risk of 

disease exposure. 

• Information on more vaccines, including new vaccines, has been added to 

the tables outlining the dose and routes of administration (Table 3.2.1) and 

recommended lower age limits (Table 3.2.2) for vaccines for travellers. 

3.3 Groups with special vaccination requirements 

• The section on vaccination of persons with a prior adverse event following 

immunisation has been expanded. Advice is provided on vaccination of 

persons with allergies, including egg allergy. 

• The section on vaccination of women who are planning pregnancy, pregnant 

or breastfeeding, and preterm infants has been updated and expanded. 

• The table of recommendations for vaccination in pregnancy (Table 3.3.1) has 

been updated to include new vaccines. 

• dTpa vaccine can be given during the third trimester of pregnancy as an 

alternative to post-partum or pre-conception vaccination. 

• The section on vaccination of immunocompromised persons, including 

transplant recipients and oncology patients, has been updated and expanded. 

• All immunocompromised persons, irrespective of age, who receive influenza 

vaccine for the first time are now recommended to receive 2 vaccine doses, at 

least 4 weeks apart, and 1 dose annually thereafter. 

• The tables of recommendations for vaccinations in solid organ transplant 

(Table 3.3.2) and haematopoietic stem cell transplant (Table 3.3.3) recipients 

have been updated to include new vaccines. 

• Information on recommendations for persons infected with human 

immunodeficiency virus (HIV) now discusses both children and adults and 

includes rotavirus, HPV, varicella and zoster vaccines. 

• The section on vaccination of persons with functional and anatomical 

asplenia has been updated to include new vaccines, and now includes a table 

(Table 3.3.5) summarising vaccine recommendations in this group. 

• The section on vaccination of persons with autoimmune diseases has been 

expanded to include those undergoing treatment with immunosuppressive 

agents and those with Guillain-Barré syndrome and other chronic conditions 

(hypopituitarism and metabolic diseases). 

• The section on vaccination of recent recipients of normal human 

immunoglobulin and other blood products has been expanded. 


• The section on vaccination of persons with bleeding disorders has been 

updated to include new recommendations for when IM injections should be 

deferred and advice regarding vaccination of persons with haemophilia. 

• The table of recommended vaccinations for persons at risk of occupationally 

acquired vaccine-preventable diseases (Table 3.3.7) has been updated to 

include new occupational groups and recommendations. 

• The section on vaccination of migrants to Australia has been expanded. 

• A new section has been added to provide recommendations for vaccination 

for sex industry workers. 

Part 4 Vaccine-preventable diseases 

4.1 Cholera 

• If the interval between primary immunisation and booster dose is more 

than 6 months in children aged 2–6 years, or more than 2 years in adults and 

children aged >6 years, primary immunisation must be repeated. 

4.2 Diphtheria, 4.19 Tetanus and 4.12 Pertussis 

• The 1st dose of DTPa-containing vaccines due at 2 months of age can be 

given as early as 6 weeks of age. 

• Advice is provided that an additional dose of pertussis-containing vaccine 

can be given in the 2nd year of life (e.g. at 18 months of age) if parents wish 

to minimise the likelihood of their child developing pertussis. 

• The booster dose of DTPa-containing vaccine recommended at 4 years of age 

can be given as early as 3.5 years. 

• DTPa-containing vaccines can be used for primary or booster doses in 

children aged

• For persons undertaking high-risk travel, a 5-yearly booster dose with dT or 

dTpa should be considered for protection against tetanus. In other travellers, 

a booster dose of tetanus-containing vaccine should be provided if 10 years 

have elapsed since the previous dose. 

• More information on the definition of ‘tetanus-prone wounds’ is provided, 

and the table (Table 4.19.1) on wound management has been updated to 

include recommendations for use of tetanus immunoglobulin (TIG) in 

immunocompromised persons. 

• Information on diphtheria antitoxin is now contained in Part 5 of 

the Handbook. 

4.3 Haemophilus influenzae type b 

• Combination Hib-meningococcal C vaccine (Hib-MenCCV) included. 

• Hib vaccination recommendations apply to all children, including Aboriginal 

and Torres Strait Islander children, as only PRP-T Hib vaccines have been in 

use in recent years. 

4.4 Hepatitis A 

• The section on serological testing for hepatitis A prior to vaccination has 

been expanded, and more detail provided as to rationale for vaccination of 

certain groups. 

• Hepatitis A vaccination is recommended in preference to NHIG for use in 

post-exposure prophylaxis in immunocompetent persons ≥12 months of age. 

4.5 Hepatitis B 

• Different schedules for hepatitis B vaccination, including minimum intervals 

between doses, have been described in more detail. 

• Advice is provided regarding the validity of a hepatitis B vaccine schedule 

used for children born overseas, who were vaccinated at birth, 1 month and 

6 months of age. 

• Information is provided on checking for infection/immunity to hepatitis B 

in infants born to mothers with chronic hepatitis B infection 3 to 12 months 

after the primary vaccine course. 

• It is now recommended that Aboriginal and Torres Strait Islander people 

have their risks and vaccination status for hepatitis B reviewed, be offered 

testing for previous hepatitis B infection, and be offered vaccination if 

non-immune. 

• Migrants from hepatitis B endemic countries should be offered testing for 

hepatitis B, and vaccination if appropriate. 

• The section on serological testing for hepatitis B prior to vaccination has 

been expanded, and more detail provided as to rationale for testing and/or 

vaccination of certain groups, including hepatitis B vaccine non-responders. 


4.6 Human papillomavirus 

• HPV vaccination is now recommended for girls at the optimal age for 

vaccination of 11–13 years. 

• HPV vaccination is now not routinely recommended for women aged 

19–26 years. A risk-benefit assessment should be conducted when 

contemplating vaccination of women in this and older age groups. 

• Recommendations for use of HPV in males have been included. HPV 

vaccination is recommended for males aged 9–18 years, with the optimal 

age for vaccination being 11–13 years. 

• Specific recommendations regarding the use of HPV vaccine in 

immunocompromised persons and men who have sex with men are 

now included. 

4.7 Influenza 

• Intradermal influenza vaccines are included. 

• Ages for which different brands of influenza vaccine are registered have been 

specified. 

• Readers are referred to the Immunise Australia website (www.immunise. 

health.gov.au) to check annual statements on influenza vaccine availability 

and recommendations for use. 

• Information on the disease burden and benefits of influenza vaccination in 

pregnancy and in children aged ≥6 months and

• MMR vaccine is to be used for the 1st dose at 12 months of age. MMRV is not 

recommended for use as the 1st dose of MMR-containing vaccine in children 

• For Aboriginal and Torres Strait Islander children living in the Northern 

Territory, Queensland, South Australia or Western Australia, a booster dose of 

13vPCV at 12–18 months of age replaces the booster dose of 23vPPV at 18–24 

months of age. 

• The list of conditions associated with increased risks of invasive 

pneumococcal disease (IPD) (List 4.13.1) has been revised to include both 

adults and children, and is now divided into two categories: those conditions 

posing the highest increased risk of developing IPD and those associated with 

an increased risk of IPD. 

• The table (Table 4.13.3) summarising recommendations for vaccination of 

adults with 23vPPV has been revised. 

• Recommendations for the use of a single dose of 13vPCV in adults and 

children >5 years of age with conditions associated with the highest increased 

risk of IPD (and who have not previously received a 13vPCV dose) are 

included. 

• Information on the use of 23vPPV in persons >5 years of age at increased risk 

of IPD has also been more clearly presented. 

4.14 Poliomyelitis 

• The 1st dose of IPV-containing combination vaccine due at 2 months of age 

can be given as early as 6 weeks of age. 

• A booster dose of IPV-containing vaccine is recommended at 4 years of age, 

but can be given as early as 3.5 years. 

4.15 Q fever 

• Q fever vaccination and skin testing training is now undertaken via an 

educational module available online. 

• Information on the Australian Q Fever Register, which lists Q fever 

immunisation service providers and records of Q fever vaccinations given to 

some persons, is included. 

• Q fever vaccination is now also recommended for professional dog and 

cat breeders, and wildlife and zoo workers who have contact with at-risk 

animals, including kangaroos and bandicoots. 

4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus) 

• The terms PEP (post-exposure prophylaxis) and PreP (pre-exposure 

prophylaxis) are used throughout the chapter. 

• Information and recommendations on management of all potential lyssavirus 

exposures, including lyssavirus infection from exposure to bats in non-rabiesenzootic 

countries, is now included. 

• A 4-dose PEP schedule is now recommended for immunocompetent 

persons. A 5-dose schedule is only recommended for persons who are 

immunocompromised. 


1.4 WHAT'S NEW

• A table (Table 4.16.1) summarising World Health Organization (WHO) 

categories of lyssavirus exposure, for guidance in use of post-exposure 

prophylaxis, has been added. 

• Algorithms are provided with details of the recommended management 

pathways for post-exposure prophylaxis for rabies and other lyssaviruses 

(including Australian bat lyssavirus), and for booster doses for persons at 

ongoing risk of exposure to rabies and other lyssaviruses. 

• Advice regarding the completion of post-exposure prophylaxis commenced 

overseas has been expanded, including the addition of a summary table 

(Table 4.16.2). 

• Persons who have completed a primary course of a currently available cell 

culture-derived rabies vaccine no longer routinely require booster doses if 

travelling or living in an area of high risk. 

• Information on the role of serological testing has been more clearly presented. 

4.17 Rotavirus 

• The upper age limits for each dose of rotavirus vaccines are more clearly 

defined. 

• Contraindications to rotavirus vaccination now include previous history of 

intussusception (IS) and severe combined immunodeficiency in infants. 

• Information on the safety of rotavirus vaccines in infants with underlying 

conditions and infants who are immunocompromised has been updated. 

• Information on adverse events following rotavirus vaccination has been 

updated and expanded, including new information on the low, but increased, 

risk of IS occurring following the 1st or 2nd dose of either rotavirus vaccine. 

4.20 Tuberculosis 

• Bacille Calmette-Guérin (BCG) vaccination is no longer routinely 

recommended for neonates weighing

Part 5 Passive immunisation 

• Information regarding the use of intravenous immunoglobulins as treatment 

for disease conditions (such as Kawasaki disease) or as replacement therapy 

for immunodeficient individuals is no longer included in the Handbook. 

Readers are referred to National Blood Authority guidelines. 


1.4 WHAT'S NEW

1.5 FUNDAMENTALS OF IMMUNISATION 

1.5.1 Overview 

Vaccines are complex biological products designed to induce a protective 

immune response effectively and safely. Vaccines contain one or more antigens 

(or immunogens) that stimulate an active immune response. These are generally 

protein- or polysaccharide (sugar)-based substances. The number and derivation 

of the antigen(s) contained in each vaccine vary. Most vaccines work by inducing 

B-lymphocytes to produce antibodies that bind to and inhibit pathogenic 

organisms or their toxins. Generation of T-cell-mediated (cellular) immunity is 

also important for some vaccines. 

Vaccines, like all medicines, are regulated in Australia by the Therapeutic Goods 

Administration (TGA). Before they are made available for use they are rigorously 

tested in human clinical trials to confirm that they are safe and that they 

stimulate protective immune responses. Vaccines are also evaluated to ensure 

compliance with strict manufacturing and production standards. This testing is 

required by law and is usually conducted both during the vaccine’s development 

and after its registration. In addition, once they are in use, the safety of vaccines 

is monitored by the TGA and other organisations using different methods, 

including passive and active surveillance for adverse events following 

immunisation (see 1.5.5 Vaccine safety and adverse events following immunisation). 

1.5.2 Passive immunisation 

Passive immunity is the direct transfer or administration of antibodies to a 

non-immune person to provide immediate protection. One example of passive 

immunisation is the transfer of maternal antibodies to the fetus, which provides 

some short-lived protection of the newborn infant against certain infections. 1,2 

Another example is the administration of a product containing antibodies 

(or immunoglobulins, IgG) pooled from blood donors, in order to provide 

temporary protection to a non-immune person who has recently been exposed to 

infection. 3 The protection afforded is immediate, but lasts for only a few weeks 

as the half-life of IgG is approximately 3 to 4 weeks. Regular immunoglobulin 

infusions are also indicated for some immunocompromised persons who are 

deficient in antibody. A separate use of immunoglobulins is in the treatment 

of a number of specific immune-mediated conditions in order to modulate 

the disease course. For further information regarding the use of intravenous 

immunoglobulin for this purpose, refer to Criteria for the clinical use of intravenous 

immunoglobulin in Australia (www.nba.gov.au/ivig/index.html). 

For more information on passive immunisation see Part 5 Passive immunisation. 

1.5.3 Active immunisation 

Active immunisation involves the use of vaccines to stimulate the immune 

system to produce a protective immune response. Vaccines usually induce 

an immune response that mimics the host’s response to natural infection, but 


without the harmful consequences of the infection itself. In addition to antibody 

responses, many vaccines also stimulate cell-mediated immunity. Immunity 

following active immunisation generally lasts for months to many years, 

depending on the nature of the vaccine as well as host factors. 4,5 Protective 

immunity is induced by antigen(s) contained within the vaccine. This may be a 

toxoid (a bacterial toxin that has been rendered non-toxigenic, e.g. for tetanus or 

diphtheria); killed or inactivated bacteria or viruses, such as hepatitis A vaccines; 

live attenuated bacteria or viruses, such as measles, mumps and rubella vaccines; 

or subunit components of a pathogen that only contain the antigen(s) of interest, 

such as the hepatitis B vaccine. 4,5 

In addition to containing the immunising antigen(s), vaccines may also contain 

the following: 

• Adjuvants, which enhance the immune response to an antigen; an example is 

aluminium hydroxide. 

• Preservatives, which reduce the risk of contamination; some examples 

are 2-phenoxyethanol, which is also used in many cosmetics and 

pharmaceuticals, and thiomersal, which is used in the Q fever vaccine but is 

not present in any of the vaccines on the National Immunisation Program for 

young children. 

• Stabilisers, which improve the shelf-life and help to protect the vaccine from 

adverse conditions; examples are sucrose, mannitol, lactose and gelatin. 

Stabilisers are also used in most confectionery and many pharmaceuticals. 

• Emulsifiers or surfactants, which alter the surface tension of the liquid 

vaccine; examples are polysorbate-80 and sorbitol. Emulsifiers are added to 

most ice creams and many pharmaceuticals. 

• Residuals, which are minute or trace amounts of substances that remain after 

the manufacture of the vaccine; examples of residuals detectable in some 

vaccines are formaldehyde, antibiotics such as neomycin or polymyxin, and 

egg proteins. 

Further details of a particular vaccine’s constituents can be found in either the 

product information (PI) or the consumer medicines information (CMI) for 

individual vaccines. This information is presented in the shaded box for each 

vaccine under the disease-specific chapters in Part 4 of this Handbook (current 

June 2012); however, it is important to note that PIs and CMIs are updated 

periodically. The most current versions of the PI (and CMI) for vaccines (and 

other medicines) are available from the TGA website (www.tga.gov.au). 

In addition, information on the components contained in vaccines that are 

available under the Australian National Immunisation Program is provided in 

Appendix 3 of this Handbook, and further details on vaccine composition can be 

found in Appendix 4 Commonly asked questions about vaccination. 


1.5 FUNDAMENTALS 

OF IMMUNISATION

The recommended number of doses and age of administration vary for each 

vaccine. These recommendations are based on the type of vaccine, disease 

epidemiology (the age-specific risk for infection and for complications), and the 

anticipated immune response of the recipient (including whether transplacental 

transfer of maternal antibodies will inhibit the immune response in an infant). 4,5 

Several doses of a vaccine may be required to induce protective immunity, 

particularly in younger children. 

Homeopathic preparations do not induce immunity and are never an alternative 

to vaccination (see Appendix 4 Commonly asked questions about vaccination). 

Detailed information on the background, available vaccines and 

recommendations for vaccines used in active immunisation are provided in the 

disease-specific chapters in Part 4 of this Handbook. 

1.5.4 Vaccine efficacy, vaccine effectiveness and vaccine failure 

The terms vaccine efficacy and vaccine effectiveness are often used 

interchangeably. However, in general terms, vaccine efficacy refers to estimates of 

protection obtained under the idealised conditions of a randomised controlled 

trial (RCT). It is usually expressed as the percentage reduction in a person’s 

risk of disease if vaccinated compared to the risk if not vaccinated. Vaccine 

effectiveness refers to estimates of protection obtained under ‘real world’ rather 

than trial conditions, for example, in immunisation programs after vaccine 

registration. Sometimes vaccine effectiveness is also taken to include the 

broader impact of a vaccination program on overall disease incidence in the 

population, including any additional herd protection conferred to unvaccinated 

individuals. 4,6 

The extent and duration of protection provided by vaccination varies and 

is influenced by many factors. For example, some vaccines, such as the 

pneumococcal and meningococcal polysaccharide vaccines, provide protection 

for a few years only. This is because polysaccharide antigens induce antibodies 

without the involvement of T-lymphocytes (T-cell independent response). T-cell 

lymphocyte involvement is needed for long-term immune memory; without it, 

protection is relatively short-lived and immunity wanes, sometimes requiring 

revaccination. In addition, polysaccharide vaccines are less immunogenic 

in children aged

(vaccine failure). Often such infections result in a milder or more attenuated form 

of disease, for example, chickenpox developing despite varicella vaccination or 

whooping cough developing after 2 or more doses of pertussis vaccine. Vaccine 

failure can be categorised in two ways. ‘Primary’ vaccine failure occurs when 

a fully vaccinated person does not form an adequate immune response to that 

vaccine. This might occur because a vaccine is defective due to a manufacturing 

fault or, more typically, because of inadequate storage (e.g. breakage of the cold 

chain) or expiry of the shelf-life. Primary vaccine failure may also occur because 

the recipient’s immune response is ineffective, which may be relatively specific 

for that vaccine or part of a broader immunodeficiency. ‘Secondary’ vaccine 

failures occur when a fully vaccinated person becomes susceptible to that disease 

over time, usually because immunity following vaccination wanes over time. 

As discussed above, the duration of the protective effect of vaccination varies 

depending on the nature of the vaccine and the type of immune response elicited, 

the number of doses received, and host factors. Some vaccinated persons may get 

further immune stimulation from natural infection or colonisation, which aids in 

maintaining ongoing protection. 

1.5.5 Vaccine safety and adverse events following immunisation 

What is an adverse event following immunisation? 

The term ‘adverse event following immunisation’ (AEFI) refers to any 

untoward medical occurrence that follows immunisation, whether 

expected or unexpected, and whether triggered by the vaccine or only 

coincidentally occurring after receipt of a vaccine. The adverse event may 

be any unfavourable or unintended sign, abnormal laboratory finding, 

symptom or disease. 7 

Adverse events following immunisation (AEFI) should be reported 

promptly, either according to relevant state or territory protocols or directly 

to the TGA (for detailed information on reporting and management of AEFI, 

see 2.3 Post-vaccination). 

The safety of vaccines is very important as vaccines are given to prevent disease 

and target all or many members of the population, most of whom are healthy. 

All vaccines available in Australia must pass stringent safety testing before being 

approved for use by the TGA. This testing is required by law and is usually 

done over many years during the vaccine’s development. In addition, the TGA 

monitors the safety of vaccines once they are registered. 

From the time a vaccine comes into use, there is ongoing review of both vaccine 

safety and efficacy through a variety of mechanisms, such as further clinical 



OF IMMUNISATION

trials and surveillance of disease and vaccine adverse events. One important 

component of ensuring that vaccines are safe is to monitor the occurrence of 

AEFI. In Australia, there are regional and national surveillance systems that 

collect reports of any adverse events following immunisation. All AEFI reported 

are added to the national Adverse Drug Reactions System (ADRS) database, 

which is operated by the TGA. (See also 2.3 Post-vaccination.) Each year, reports 

presenting data and analysis of AEFI in Australia are published in the journal 

Communicable Diseases Intelligence, accessible via the Australian Government 

Department of Health and Ageing website (www.health.gov.au/internet/main/ 

publishing.nsf/content/cda-pubs-cdi-cdiintro.htm). 

In some cases, other specific studies will be conducted to ensure that vaccine 

safety is closely monitored once a vaccine is in use. For example, the risk of 

intussusception (IS) following rotavirus vaccines has been closely monitored 

in Australia and elsewhere because of the association of a previously licensed 

vaccine with an unacceptably high risk of IS. 

Adverse reactions to vaccines (also known as ‘vaccine side effects’) do sometimes 

occur. It is usually not possible to predict which individuals may have a mild 

or, rarely, a serious reaction to a vaccine. However, by following guidelines 

regarding when vaccines should and should not be used, the risk of adverse 

events can be minimised. As vaccines are usually given to healthy people, any 

adverse event that follows soon after immunisation may be perceived as due to 

the vaccine. The fact that an adverse event occurs after an immunisation does not 

prove the vaccine caused the event. A causal association is rarely certain, but is 

most likely when the AEFI is both typical (even if very rare) and when there is 

no other plausible explanation, for example, an injection site reaction occurring 

a day after vaccination or typical anaphylaxis occurring within minutes of 

vaccination. Many AEFIs are less specific and/or have plausible alternative 

explanations, including coincidence. Such associations can only be assessed by 

large-scale epidemiological studies or specific tests, for example, in the case of 

allergy, by allergy testing or challenge. Even when an AEFI is typical, it may be 

nonetheless unrelated to vaccination (see 2.3 Post-vaccination). 

Vaccine adverse events fall into two general categories: local or systemic. Local 

reactions are defined as reactions occurring at the site of vaccine administration 

(usually pain, redness or swelling at the injection site) and are generally the least 

severe and most frequently occurring AEFI. Systemic reactions most commonly 

include fever, headache and lethargy. 8,9 Allergic reactions can also occur, although 

anaphylaxis, the most severe form of an allergic response, is rarely caused by 

vaccination. It is not possible to completely predict which individuals may have a 

reaction to a vaccine. 

Each chapter in the Handbook indicates under which circumstances vaccine 

administration is contraindicated or where precautions are required. A 

contraindication to vaccination usually occurs when a person has a pre-existing 

condition that significantly increases the chance that a serious adverse event 


will occur following receipt of a specific vaccine. A contraindication may also 

occur when there is insufficient safety data regarding a vaccine’s use and there 

is a theoretical risk of harm. In general, vaccines should not be given where a 

contraindication exists, except under advice from your local state or territory 

health department (Appendix 1 Contact details for Australian, state and territory 

government health authorities and communicable disease control). 

A precaution is a condition that may increase the chance of an adverse event 

following immunisation or one that may compromise the ability of the vaccine 

to produce immunity. When a precaution exists, there may still be circumstances 

when the benefits of giving the vaccine outweigh the potential risks; however, 

special care and the provision of appropriate advice to the vaccine recipient may 

be required (see 3.3.1 Vaccination of persons who have had an adverse event following 

immunisation). 

In 2010, a national review of the management of adverse events that occurred 

following influenza vaccine administration was performed. 10 The review made a 

number of recommendations to further improve the monitoring of vaccine safety 

in Australia. Any changes to the system(s) for monitoring or reporting of AEFI 

in Australia will be reflected in future updates to the Handbook and will also be 

available from the Immunise Australia website (www.immunise.health.gov.au). 

References 





OF IMMUNISATION

PART 2 VACCINATION PROCEDURES 

In Australia, vaccination is undertaken predominantly through general practices, 

but in some jurisdictions vaccines may be given through local council clinics, 

community centres or through school-based immunisation programs. In some 

situations, vaccinations may also be given in travel medicine clinics, public 

hospitals, staff occupational health clinics and aged care facilities. State or 

territory legislation outlines who can access and administer vaccines. All vaccines 

must be administered in accordance with the relevant legislation, best practice 

and the following Handbook guidelines and recommendations. 

2.1 PRE-VACCINATION 

The following sections discuss steps and procedures that should occur before a 

vaccination encounter. 

2.1.1 Preparing an anaphylaxis response kit 

The availability of protocols, equipment and drugs necessary for the 

management of anaphylaxis should be checked before each vaccination session. 

An anaphylaxis response kit should be on hand at all times and should contain: 

• adrenaline 1:1000 (minimum of three ampoules – check expiry dates) 

• minimum of three 1 mL syringes and 25 mm length needles (for 

intramuscular [IM] injection) 

• cotton wool swabs 

• pen and paper to record time of administration of adrenaline 

• laminated copy of adrenaline doses (Table 2.3.2 or back cover of this 

Handbook) 

• laminated copy of ‘Recognition and treatment of anaphylaxis’ (back cover 

of this Handbook). 

See 2.3.2 Adverse events following immunisation for details on recognition and 

treatment of adverse events following immunisation (in particular, see ‘Use of 

adrenaline’ and ‘Use of adrenaline autoinjectors for anaphylaxis treatment’ in 

that section). 

2.1.2 Effective cold chain: transport, storage and handling of vaccines 

The cold chain is the system of transporting and storing vaccines within the 

temperature range of +2°C to +8°C from the place of manufacture to the point 

of administration. 1 Maintenance of the cold chain is essential for maintaining 

vaccine potency and, in turn, vaccine effectiveness. This is vital, not only for 

those vaccines provided as part of the National Immunisation Program, but also 

for vaccines purchased by the patient via prescription from a pharmacist. In such 


cases, both the doctor issuing the prescription and the pharmacist dispensing 

the vaccine must inform the patient of the need for maintaining, and how to 

maintain, the cold chain for the vaccine they have purchased. 

All immunisation service providers must be familiar with, and adhere 

to, the National vaccine storage guidelines: Strive for 5. 1 This publication can 

be accessed free of charge from www.immunise.health.gov.au/internet/ 

immunise/publishing.nsf/Content/provider-store 

The National vaccine storage guidelines: Strive for 5 contains specific details on 

setting up the infrastructure for a vaccination service, and immunisation service 

providers should refer to this document to ensure that satisfactory equipment 

and procedures are in place before commencing vaccination services. 1 

These guidelines also provide instructions on how best to transport vaccines 

from the main storage facility to outreach or external clinics. Purpose-built 

vaccine refrigerators (PBVR) are the preferred means of storage for vaccines. 

Domestic refrigerators are not designed for the special temperature needs of 

vaccine storage. 

Cold chain breaches 

Despite best practices, cold chain breaches sometimes occur. It is important 

to report any cold chain breaches so that revaccination of patients or recall of 

unused vaccines can be undertaken, if required. 

Do not discard or use any vaccines exposed to temperatures below +2°C or 

above +8°C without obtaining further advice. Isolate vaccines and contact 

the state/territory health authorities (see Appendix 1) for advice on the 

National Immunisation Program vaccines and the manufacturer/supplier 

for privately purchased vaccines. Recommendations for the discarding of 

vaccines may differ between health authorities and manufacturers. 

2.1.3 Valid consent 

Valid consent can be defined as the voluntary agreement by an individual to a 

proposed procedure, given after sufficient, appropriate and reliable information 

about the procedure, including the potential risks and benefits, has been 

conveyed to that individual. 2-6 As part of the consent procedure, persons to be 

vaccinated and/or their parents/carers should be given sufficient information 


2.1 PRE-VACCINATION

(preferably written) on the risks and benefits of each vaccine, including what 

adverse events are possible, how common they are and what they should do 

about them7 (the table inside the front cover of this Handbook, Side effects following 

immunisation for vaccines used in the National Immunisation Program (NIP) schedule, 

can be used for this purpose). 

For consent to be legally valid, the following elements must be present: 6,8 

1. It must be given by a person with legal capacity, and of sufficient intellectual 

capacity to understand the implications of being vaccinated. 

2. It must be given voluntarily in the absence of undue pressure, coercion or 

manipulation. 

3. It must cover the specific procedure that is to be performed. 

4. It can only be given after the potential risks and benefits of the relevant 

vaccine, risks of not having it and any alternative options have been 

explained to the individual. 

The individual must have sufficient opportunity to seek further details or 

explanations about the vaccine(s) and/or its administration. The information 

must be provided in a language or by other means the individual can 

understand. Where appropriate, an interpreter and/or cultural support person 

should be involved. 

Consent should be obtained before each vaccination, once it has been established 

that there are no medical condition(s) that contraindicate vaccination. Consent 

can be verbal or written. Immunisation providers should refer to their state or 

territory’s policies on obtaining written consent (see Appendix 1 Contact details 

for Australian, state and territory government health authorities and communicable 

disease control). 

Consent on behalf of a child or adolescent 

In general, a parent or legal guardian of a child has the authority to consent to 

vaccination of that child; however, it is important to check with your state or 

territory authority where any doubt exists. 2,5 A child in this context is defined 

as being under the age of 18 years in Tasmania, Victoria and Western Australia; 

under the age of 14 years in New South Wales; and under the age of 16 years 

in the Australian Capital Territory, South Australia and the Northern Territory. 

Queensland follows common law principles. 

For certain procedures, including vaccination, persons younger than the ages 

defined above may have sufficient maturity to understand the proposed 

procedure and the risks and benefits associated with it, and thus may have the 

capacity to consent under certain circumstances. Refer to the relevant state or 

territory immunisation service provider guidelines for more information. 


Should a child or adolescent refuse a vaccination for which a parent/guardian 

has given consent, the child/adolescent’s wishes should be respected and the 

parent/guardian informed. 2 

Consent on behalf of an adult lacking capacity 

A careful assessment should be made of an adult’s capacity to give valid consent 

to a vaccination. If the adult lacks capacity, practitioners should refer to relevant 

state and territory laws relating to obtaining consent from a substitute decisionmaker. 

For example, this may occur for influenza vaccination of an elderly person 

with dementia. Refer to the enduring guardianship legislation appropriate for 

your state or territory for further advice. 

Resources to help communicate the risks and benefits of vaccines 

Plain language should be used when communicating information about vaccines 

and their use. The person to be vaccinated (or their parent/guardian) must be 

encouraged and allowed to ask for further information and have sufficient time 

to make a decision about whether to consent or not. 9,10 

It is preferable that printed information is available to supplement any verbal 

explanations. 11 The summary table Comparison of the effects of diseases and the side 

effects of NIP vaccines inside the back cover of this Handbook provides some basic 

information necessary to communicate the risks and benefits of vaccination. 

The table can be photocopied and used freely as required. 

More detailed information concerning vaccines and their use is available from 

the following sources: 

• www.immunise.health.gov.au 

The Immunise Australia website includes the booklet Understanding childhood 

immunisation, which contains frequently asked questions and links to 

state and territory health department websites. Several of these sites offer 

multilingual fact sheets. 

• www.ncirs.edu.au 

The National Centre for Immunisation Research and Surveillance of Vaccine 

Preventable Diseases website includes fact sheets related to specific vaccines, 

vaccine-preventable diseases and vaccine safety. The website also hosts 

online decision aids to assist patients in deciding whether to vaccinate or not. 

See also Appendix 4 Commonly asked questions about vaccination. 

Evidence of consent 

General practice or public immunisation clinics 

Consent may be given either in writing or verbally, according to the protocols 

of the health facility, but it must meet the criteria for valid consent. Evidence 

of verbal consent should be documented in the clinical records. If a standard 

procedure is routinely followed in a practice or clinic, then a stamp, a sticker 


2.1 PRE-VACCINATION

or a provider’s signature indicating that the routine procedure has been 

followed may be used. For paperless medical records, a typed record of 

verbal consent may be made in the patient’s file, or a copy of written consent 

scanned into the file. 

Explicit verbal consent is required before administration of any vaccine, even 

when written consent has been given at previous vaccination encounters for the 

same vaccine. Verbal consent should be documented in the patient’s file each 

time it is given. 

School-based vaccination programs 

Consent is required for provision of individual vaccines or a vaccine course 

offered in school-based vaccination programs. 

In school-based, and other large-scale, vaccination programs, the parent or 

guardian usually does not attend with the child on the day the vaccination is 

given, and written consent from the parent or guardian is desirable in these 

circumstances. However, if written consent is not able to be provided, or if 

further clarification is required, verbal consent may be sought by telephone 

from the parent or guardian by the immunisation service provider. This should 

be clearly documented on the child’s consent form. In some jurisdictions, 

older adolescents may be able to provide their own consent for vaccinations 

offered through school-based vaccination programs. 12 Consent requirements 

and vaccines offered in these programs vary between jurisdictions. Refer to the 

relevant state or territory school-based vaccination program guidelines for more 

information. 

2.1.4 Pre-vaccination screening 

Immunisation service providers should perform a comprehensive prevaccination 

health screen of all persons to be vaccinated. For some individuals, 

alterations to the routinely recommended vaccines may be necessary to either 

eliminate or minimise the risk of adverse events, to optimise an individual’s 

immune response, or to enhance the protection of a household contact against 

vaccine-preventable diseases. 

Providers should: 

• ensure that they have the right person to be vaccinated 

• ensure which vaccine(s) are indicated, including any previously 

missed vaccine doses 

• consider whether alternative or additional vaccines should be given 

• check if there are any contraindications or precautions to the vaccines 

that are to be given 

• ensure that the patient to be vaccinated is the appropriate age for the 

vaccines to be given 


• check that the correct time interval has passed since any previous vaccine(s) 

or any blood products were given. 

See also 2.1.5 Catch-up and relevant disease chapters for further details. 

Steps for pre-vaccination screening 

Follow these steps to complete the pre-vaccination screening process: 

• Provide the person to be vaccinated or the parent/carer with the Prevaccination 

screening checklist (Table 2.1.1). 

» Some of the questions in this checklist are deliberately non-specific so as to 

elicit as much important information as possible. 

» The checklist may be photocopied and handed to the person to be 

vaccinated or the parent/carer just before vaccination. 

» The checklist may also be photocopied and displayed in the clinic/surgery 

for easy reference for the immunisation service provider. 

• For vaccination of adults, seek additional information about the occupation 

and lifestyle factors that may influence vaccination requirements. This is 

discussed in more detail in 2.1.5 Catch-up below under ‘Catch-up schedules 

for persons ≥10 years of age’. 

• If you identify the presence of a condition or circumstance indicated on the 

pre-vaccination screening checklist, refer to Table 2.1.2, which lists the specific 

issues pertaining to such condition(s) or circumstances and provides the 

appropriate action with a rationale. 

• Where necessary, seek further advice from a specialist immunisation clinic, 

a medical practitioner with expertise in vaccination, the immunisation 

section within your state or territory health authority, or your local Public 

Health Unit (see Appendix 1 Contact details for Australian, state and territory 



2.1 PRE-VACCINATION

Table 2.1.1: Pre-vaccination screening checklist 

Pre-vaccination screening checklist 

This checklist helps decide about vaccinating you or your child today. Please 

fill in the following information for your doctor/nurse. 

Name of person to be vaccinated ______________________________________ 

Date of birth ________________ 

Age today __________________ 

Name of person completing this form __________________________________ 

Please indicate if the person to be vaccinated: 

is unwell today 

has a disease that lowers immunity (e.g. leukaemia, cancer, HIV/AIDS) or is 

having treatment that lowers immunity (e.g. oral steroid medicines such as 

cortisone and prednisone, radiotherapy, chemotherapy) 

has had a severe reaction following any vaccine 

has any severe allergies (to anything) 

has had any vaccine in the past month 

has had an injection of immunoglobulin, or received any blood products or 

a whole blood transfusion within the past year 

is pregnant 

has a past history of Guillain-Barré syndrome 

was a preterm infant 

has a chronic illness 

has a bleeding disorder 

identifies as an Aboriginal or Torres Strait Islander 

does not have a functioning spleen 

is planning a pregnancy or anticipating parenthood 

is a parent, grandparent or carer of a newborn 

lives with someone who has a disease that lowers immunity (e.g. leukaemia, 

cancer, HIV/AIDS), or lives with someone who is having treatment 

that lowers immunity (e.g. oral steroid medicines such as cortisone and 

prednisone, radiotherapy, chemotherapy) 

is planning travel 

has an occupation or lifestyle factor(s) for which vaccination may be needed 

(discuss with doctor/nurse) 

Please specify:__________________________________________________ 


Note: Please discuss this information or any questions you have about 

vaccination with your doctor/nurse before the vaccines are given. 

Before any vaccination takes place, your doctor/nurse should ask you: 

Did you understand the information provided to you about vaccination? 

Do you need more information to decide whether to proceed? 

Did you bring your/your child’s vaccination record card with you? 

It is important for you to receive a personal record of your or your child’s 

vaccinations. If you do not have a record, ask your doctor/nurse to give 

you one. Bring this record with you every time you or your child visit for 

vaccination. Make sure your doctor/nurse records all vaccinations on it. 

Conditions or circumstances identified using the pre-vaccination 

screening checklist 

The recommended responses for immunisation service providers to make if any 

conditions or circumstances are identified by using the pre-screening checklist 

are summarised in Table 2.1.2. 

Note: Only vaccines recommended on the NIP schedule are included in Table 

2.1.2. For information on other vaccines, refer to the relevant disease-specific 

chapter in Part 4 of this Handbook or to vaccine product information. 

For reference, Table 2.1.3 provides a list of live attenuated vaccines. 

Table 2.1.2: Responses to relevant conditions or circumstances identified 

through the pre-vaccination screening checklist 

Condition or 

circumstance of person 

to be vaccinated 

Is unwell today: 

• acute febrile illness 

(current T ≥38.5°C) 

• acute systemic 

illness 

Action Rationale 13-15 

Defer all vaccines until 

afebrile. 

Note: Children with minor 

illnesses (without acute 

systemic symptoms/signs) 

should be vaccinated. 

To avoid an adverse event 

in an already unwell child, 

or to avoid attributing 

symptoms to vaccination 


2.1 PRE-VACCINATION

Condition or 



Has a disease that 

lowers immunity or is 

receiving treatment that 

lowers immunity 

Has had anaphylaxis 

following a previous 

dose of the relevant 

vaccine 

Has a severe allergy to a 

vaccine component 

Has received a live 

attenuated viral 

parenteral vaccine* or 

BCG vaccine in past 4 

weeks 


Refer to 3.3.3 Vaccination 

of immunocompromised 

persons. 

In some cases, expert 

advice may need to be 

sought before vaccination 

(see Appendix 1). 

Note: Persons living with 

someone with lowered 

immunity should be 

vaccinated, including with 

live viral vaccines (see 

below). 

Do not vaccinate. Seek 

further medical advice 

to confirm causality 

and to assist with other 

vaccinations. 

See also ‘Contraindications 

to vaccination’ below. 

Refer to Appendix 3 for 

a vaccine component 

checklist. 

Do not vaccinate but seek 

specialist advice (see 

Appendix 1). The patient 

may still be able to be 

vaccinated, dependent on 

the allergy. 

Delay live attenuated 

viral parenteral vaccines 

by 4 weeks. 

32 The Australian Immunisation Handbook 10th edition 

The safety and 

effectiveness of the vaccine 

may be suboptimal 

in persons who are 


Live attenuated vaccines 

may be contraindicated. 

Anaphylaxis to a 

previous dose of vaccine 

is a contraindication to 

receiving the same vaccine. 

Anaphylaxis to a vaccine 

component is generally 

a contraindication to 

receiving the vaccine. 

The immune response 

to a live attenuated 

viral vaccine (given 

parenterally) may interfere 

with the response to a 

subsequent live viral 

vaccine given within 4 

weeks of the first.

Condition or 



Has had any blood 

product in the past 

7 months, or has 

had IM or IV 

immunoglobulin 

in the past year 

Is planning a pregnancy 

or anticipating 

parenthood 


Check which product 

the person received 

and the interval since 

administration. Refer to 

Table 3.3.6 Recommended 

intervals between either 

immunoglobulins or blood 

products and MMR, MMRV 

or varicella vaccination. 

If not eligible, make a 

return appointment for this 

vaccination, and send a 

reminder later if necessary. 

Ensure women planning 

pregnancy and household 

members have received 

vaccines recommended 

for their age group. For 

example, 2nd dose of 

MMR † (if born after 1966); 

varicella; dTpa; ‡ and/ 

or have had appropriate 

pre-conception serological 

testing. 

See 3.3.2 Vaccination of 

women who are planning 

pregnancy, pregnant or 

breastfeeding, and preterm 

infants. 

Advise women not to 

become pregnant within 

28 days of receiving live 

viral vaccines.* 

Antibodies in these 

products may interfere 

with the immune response 

to MMR, MMRV and 

varicella vaccines. 

The recommended 

interval to vaccination 

varies depending on the 

immunoglobulin or blood 

product administered. 

Vaccinating before 

pregnancy may prevent 

maternal illness, which 

could affect the infant, 

and may confer passive 

immunity to the newborn. 


2.1 PRE-VACCINATION

Condition or 




Is pregnant Refer to Table 3.3.1 

Recommendations for 

vaccination in pregnancy. 

Has a history of 

Guillain-Barré syndrome 

(GBS) 

Influenza vaccine is 

recommended for all 

pregnant women. 

Live vaccines* should 

be deferred until after 

delivery. 

Vaccination of household 

contacts of pregnant 

women should be 

completed according to the 

NIP schedule. 

See 3.3.3 Vaccination of 

immunocompromised persons 

and 4.7 Influenza. 

Risks and benefits of 

influenza vaccine should 

be weighed against the 

potential risk of GBS 

recurrence (seek further 

advice as per Appendix 1). 

Was born preterm See 3.3.2 Vaccination of 

women who are planning 

pregnancy, pregnant or 

breastfeeding, and preterm 

infants. 

Preterm infants born at 

Condition or 



Has a severe or 

chronic illness 


See 3.3 Groups with special 

vaccination requirements. 

These persons should 

receive recommended 

vaccines such as 

pneumococcal vaccine 

and annual influenza 

vaccination. 

If there is significant 

immunocompromise, they 

should not receive live 

vaccines* (see above). 

Has a bleeding disorder See 3.3.5 Vaccination 

of persons with bleeding 

disorders. 

The subcutaneous route 

could be considered 

as an alternative to the 

intramuscular route; seek 

specialist advice (see 

Appendix 1). 

Identifies as an 

Aboriginal or Torres 

Strait Islander 

Does not have a 

functioning spleen 

See 3.1 Vaccination for 

Aboriginal and Torres Strait 

Islander people. 

See the National 

Immunisation Program for 

specific recommendations 

for Aboriginal and Torres 

Strait Islander people. 

See 3.3.3 Vaccination 

of immunocompromised 

persons, ‘Persons with 

functional or anatomical 

asplenia’. 

Check the person’s 

vaccination status 

for pneumococcal, 

meningococcal, influenza 

and Hib vaccinations. 

Persons with a severe or 

chronic illness may be at 

increased risk of vaccinepreventable 

diseases (e.g. 

invasive pneumococcal 

disease), but may not 

mount an optimal immune 

response to certain 

vaccines. 

The safety and 

effectiveness of some 

vaccines may be 

suboptimal in persons who 

are immunocompromised 

(see above). 

Intramuscular injection 

may lead to haematomas 

in patients with disorders 

of haemostasis. 

Some Indigenous persons 

are at increased risk of 

some vaccine-preventable 

diseases, such as influenza, 

pneumococcal disease and 

hepatitis A. 

Persons with an absent 

or dysfunctional spleen 

are at an increased risk of 

severe bacterial infections, 

most notably invasive 

pneumococcal disease. 


2.1 PRE-VACCINATION

Condition or 



Is a parent, grandparent 

or carer of an infant 

≤6 months of age 

Lives with someone who 

is immunocompromised 


Ensure parents, 

grandparents and carers of 

infants up to 6 months of 

age have been offered all 

vaccines recommended for 

their age group, including 

dTpa. ‡ 

Ensure all recommended 

vaccines (in particular 

MMR, varicella and 

influenza vaccines) 

have been offered to 

household members of 

immunocompromised 

persons. 

See above and 

3.3.3 Vaccination of 


persons. 

Is planning travel See 3.2 Vaccination for 

international travel 

Has certain occupation 

or lifestyle factors 

See 3.3 Groups with special 

vaccination requirements, 

and ‘Catch-up schedules 

for persons ≥10 years 

of age’ in 2.1.5 Catch-up 

below. 

* Live attenuated vaccines are classified in Table 2.1.3 below. 

† See 4.9 Measles, 4.11 Mumps or 4.18 Rubella for further information. 

‡ See 4.2 Diphtheria, 4.12 Pertussis or 4.19 Tetanus for further information. 


Persons in close contact 

are the most likely sources 

of vaccine-preventable 

diseases, in particular 

pertussis, in the newborn. 

Household members are 

the most likely sources 

of vaccine-preventable 

diseases among 


persons (who often are 

unable to be vaccinated, 

especially with live viral 

vaccines). 

Travellers may be at 

increased risk of certain 

vaccine-preventable 

diseases. 

Workers in certain 

occupations (e.g. 

healthcare workers and 

persons working in early 

childhood education and 

care), and those with 

certain lifestyle factors (e.g. 

persons who inject drugs) 

may be at increased risk of 

certain vaccine-preventable 

diseases.

Table 2.1.3: Live attenuated parenteral and oral vaccines 

Live attenuated parenteral vaccines Live attenuated oral vaccines 

Viral Bacterial Viral Bacterial 

Japanese encephalitis 

(Imojev) 

Measles-mumpsrubella 

(MMR) 

Measles-mumpsrubella-varicella 

(MMRV) 

Varicella 

Yellow fever 

Zoster 

BCG Oral rotavirus 

vaccine 

Oral typhoid 

vaccine 

Contraindications to vaccination 

There are only two absolute contraindications applicable to all vaccines: 

• anaphylaxis following a previous dose of the relevant vaccine 

• anaphylaxis following any component of the relevant vaccine. 

There are two further contraindications applicable to live (both parenteral and 

oral) vaccines: 

• Live vaccines (see Table 2.1.3) should not be administered to persons 

who are significantly immunocompromised, regardless of whether the 

immunocompromise is caused by disease or treatment. The exception 

is that, with further advice, MMR, varicella and zoster vaccines can be 

administered to HIV-infected persons in whom immunocompromise is 

mild. (See 3.3.3 Vaccination of immunocompromised persons, and individual 

disease-specific chapters.) 

• In general, live vaccines should not be administered during pregnancy, 

and women should be advised not to become pregnant within 28 days of 

receiving a live vaccine (see Table 3.3.1 Recommendations for vaccination in 

pregnancy in 3.3 Groups with special vaccination requirements). 

False contraindications to vaccination 

No-one should be denied the benefits of vaccination by withholding 

vaccines for inappropriate reasons. 

Conditions listed in Table 2.1.4 below are not contraindications to 

vaccination. Persons with these conditions should be vaccinated with all 

recommended vaccines. 


2.1 PRE-VACCINATION

Table 2.1.4: False contraindications to vaccination 

The following conditions are not contraindications to any of the vaccines in the 

National Immunisation Program schedule: 

• mild illness without fever (T

An online ‘catch-up calculator’ for NIP vaccines is hosted by South Australia 

Health (at immunisationcalculator.sahealth.sa.gov.au) and is available to assist in 

determining appropriate catch-up schedules for children ≤7 years of age across 

Australia. When using such resources, also check the accuracy of information 

provided by referring to your current state/territory immunisation schedule and 

the current edition of the Handbook. 

If still uncertain about how to plan the catch-up schedule, or for more 

complicated catch-up scenarios, seek further advice (see Appendix 1 Contact 

details for Australian, state and territory government health authorities and 

communicable disease control). 

For recently arrived migrants, the World Health Organization website (www. 

who.int/countries/en) lists immunisation schedules provided by other countries, 

which may supplement information regarding which vaccines a child/adult 

arriving from overseas may have received (see also 3.3.8 Vaccination of migrants 

to Australia). 

Confirmation of vaccination history 

The most important requirement for assessment of vaccination status is to have 

written documentation of vaccination. The approach of immunisation service 

providers to the problem of inadequate records should be based on the age of the 

person to be vaccinated, whether previous vaccines have been given in Australia 

or overseas, and the vaccines being considered for catch-up. 

Detailed information on the vaccine registers used in Australia and how to 

obtain vaccination records is provided in 2.3.4 Immunisation registers, but is also 

described briefly below. 

Children

a person who is now ≥7 years of age can be made available to an immunisation 

service provider or parent/carer. 

The National HPV Vaccination Program Register (NHVPR, also referred to as 

the ‘HPV Register’) holds details of human papillomavirus (HPV) vaccinations 

reported to the Register since the commencement of the HPV Vaccination 

Program in April 2007. The NHVPR initially only recorded vaccinations for 

females, but from 2013 will also record vaccinations given to males. Details of 

HPV vaccinations held by the NHVPR can be obtained by phoning the Register 

on 1800 478 734 (1800 HPV REG). (See also 2.3.4 Immunisation registers.) 

In older children and adolescents, alternative sources of documentation (such as 

personal health records) will be needed, but are less likely to be available with 

increasing age. Persons who do not have personal vaccination records may seek 

evidence of past vaccination from their parents, their past and present healthcare 

providers or immunisation service providers. Those born after 1990 may have 

some vaccinations recorded on the ACIR (see 2.3.4 Immunisation registers). 

Information on how to obtain records of vaccines received through school-based 

vaccination programs can be obtained from state and territory government health 

departments (see Appendix 1 Contact details for Australian, state and territory 


Adults (≥18 years of age) 

In adults, patient-held and/or provider-held documentation of previous 

vaccination history may not be available. In some cases, information may be 

available from other sources, such as the National HPV Vaccination Program 

Register and the Australian Q Fever Register. (See also 2.3.4 Immunisation 

registers.) 

Incomplete documentation of prior vaccination 

If receipt of prior vaccination cannot be confirmed via the above methods, it 

should generally be assumed that the vaccine(s) required have not been given 

previously. All efforts should be made to confirm and ensure appropriate 

documentation of prior receipt of vaccines. 

For most vaccines (except Q fever), there are no adverse events associated with 

additional doses if given to an already immune person. In the case of diphtheria-, 

tetanus- and pertussis-containing vaccines and pneumococcal polysaccharide 

vaccines, frequent additional doses may be associated with an increase in local 

adverse events; however, the benefits of protection may outweigh the risk of an 

adverse reaction, for example, protection against pertussis from a booster dose 

of dTpa. (See also 4.2 Diphtheria, 4.12 Pertussis, 4.13 Pneumococcal disease or 4.19 

Tetanus.) Additional doses of MMR, varicella, inactivated poliomyelitis (IPV) or 

hepatitis B vaccines are rarely associated with significant adverse events. 


Use of serological testing to guide catch-up vaccination 

In some instances, serological testing for immunity from prior vaccination and/ 

or infection may be useful to guide the need for catch-up vaccination, such 

as for measles, hepatitis B and rubella. However, it is important to note that 

serological testing is not reliable for vaccine-induced immunity in all instances 

and is specifically not recommended to be used to guide the need for catch-up 

vaccination for certain diseases/vaccines (e.g. pertussis, pneumococcal disease 

and meningococcal disease). In most circumstances, and for most vaccines, it 

is more practical to offer vaccination, rather than serological testing. See also 

recommendations regarding serological testing before and after vaccination in 

various disease chapters (4.4 Hepatitis A, 4.5 Hepatitis B, 4.9 Measles, 4.11 Mumps, 

4.18 Rubella, 4.22 Varicella, 4.24 Zoster). 

Interpretation of the results of serological testing may be enhanced by discussion 

with the laboratory that performed the test, ensuring that relevant clinical 

information is provided. 

Determining when a vaccine dose is valid according to age and interval 

since last dose 

A ‘valid’ vaccine dose is a dose that is considered immunogenic (and safe) given 

the age and health status of the recipient and the interval since the recipient’s 

last dose of the same vaccine. For children who are vaccinated at an age younger 

than that routinely recommended, or for children and adults in whom the 

interval between vaccine doses is shorter than the usual recommended interval, 

information regarding both the minimum acceptable age for the 1st dose of 

an infant vaccine (Table 2.1.5) and the minimum acceptable intervals between 

vaccine doses (Tables 2.1.7 to 2.1.12) can be used to determine whether additional 

vaccine doses and/or catch-up vaccination is required. For more details see the 

following sections. 

Planning catch-up vaccination 

This and the following two sections are dedicated to planning catch-up 

vaccination. In the following two sections information is presented by age 

of the vaccine recipient (children aged

• Table 2.1.6 can be used to assess the number of doses a child should have 

received if they were on schedule. Check under the current age of the child 

to see how many doses they should have already received and use that 

number of doses as the starting point for calculating a catch-up schedule. 

For example, a child who is 18 months old now should have received 

3 doses of DTPa, 3 doses of IPV, etc. 

• Table 2.1.7 lists the minimum acceptable interval between doses under special 

circumstances, such as catch-up vaccination. Vaccine doses should not be 

administered at less than the acceptable minimum interval. 16 In the majority 

of instances, doses administered earlier than the minimum acceptable 

interval should not be considered as valid doses and should be repeated, 

as appropriate, using Table 2.1.6. 

• Tables 2.1.8 to 2.1.11 are for calculating catch-up for Haemophilus influenzae 

type b (Hib) and pneumococcal vaccination of children. 

• Table 2.1.12 can be used to calculate a catch-up schedule for persons 

aged ≥10 years. 

In addition, the following principles should generally be applied when planning 

catch-up vaccination: 

• When commencing the catch-up schedule, the standard scheduled interval 

between doses may be reduced or extended, and the numbers of doses 

required may reduce with age. For example, from 15 months of age, only 

1 dose of (any) Hib vaccine is required. 

• As a child gets older, the recommended number of vaccine doses may change 

(or even be omitted from the schedule), as the child becomes less vulnerable 

to specific diseases. 

• For incomplete or overdue vaccinations, build on the previous documented 

doses. In almost every circumstance, it is advisable to not start the schedule 

again, regardless of the interval since the last dose, but to count previous 

doses. One exception to this rule is for oral cholera vaccine (see 4.1 Cholera). 

• If more than one vaccine is overdue, 1 dose of each due or overdue vaccine 

should be given at the first catch-up visit. Further required doses should be 

scheduled after the appropriate minimum interval (see Table 2.1.7). 

• A catch-up schedule may require multiple vaccinations at a visit. Give all the 

due vaccines at the same visit – do not defer. See 2.2.9 Administering multiple 

vaccine injections at the same visit. 

• The standard intervals and ages recommended in the NIP schedule should be 

used once the child or adult is up to date with the schedule. 

• Some persons will require further doses of antigens that are available only 

in combination vaccines. In general, the use of the combination vaccine(s) 

is acceptable, even if this means the number of doses of another antigen 

administered exceeds the required number. 


• For some vaccines, catch-up vaccination is not recommended. For 

example, rotavirus vaccination is not recommended if the 1st (and 

subsequent) vaccine doses are not able to be provided within the 

prescribed upper age limits (see ‘Catch-up guidelines for individual 

vaccines for children

5. If any variations to the schedule are necessary due to recorded factors (e.g. a 

child who is immunocompromised may require different vaccines), adjust the 

‘number of doses required’ accordingly. 

6. For each vaccine, compare the number of doses received, as recorded in the 

‘Last dose given’ column, with the number of doses required for the child’s 

current age. 

7. If the child has already received the number of doses required for a 

particular vaccine, cross through the relevant ‘Dose number due now’ and 

‘Further doses’ columns. Ensure that the minimum acceptable interval has 

been observed for all doses previously received, particularly if the child 

commenced their vaccination program overseas. 

8. If the number of doses received, as recorded in the ‘Last dose given’ column, 

is less than the number of doses required, administer a dose of the relevant 

vaccine now, and record this in the ‘Dose number due now’ column. If 

this dose still does not complete the required doses, enter the further dose 

numbers in the ‘Further doses’ column. 

9. To schedule the next dose at the most appropriate time (usually at the 

earliest opportunity), refer to Table 2.1.7 for the minimum acceptable interval 

required between doses. Record when the next dose is due in the ‘Further 

doses’ column. 

10. Convert this information into a list of proposed appointment dates, 

detailing vaccines and dose number needed at each visit on the ‘Catch-up 

appointments’ section of the worksheet. 

11. Record this catch-up schedule in your provider records and provide a copy to 

the child’s parent/carer. 

12. Once a child has received relevant catch-up vaccines, give the remaining 

scheduled vaccines as per the recommended NIP schedule. For example, for a 

12-month-old child who is brought up to date with all vaccines including the 

12-month vaccinations, the 2nd dose of MMR-containing vaccine should be 

given at 18 months of age, not 4 weeks after the last received dose. 


Figure 2.1.1: Catch-up worksheet for children

Table 2.1.5: Minimum acceptable age for the 1st dose of scheduled vaccines in 

infants in special circumstances* 

Vaccine Minimum age 

for 1st dose 

in special 

circumstances* 


Action if a vaccine dose is inadvertently 

administered prior to the recommended 

minimum age 17 

DTPa 6 weeks If the 1st dose of DTPa-containing vaccine 

was administered at ≤28 days of age, it is 

recommended that the dose is repeated. This 

repeat dose should be given at 2 months of age. 

The NIP schedule should be followed thereafter, 

with the next dose of DTPa-containing vaccine 

given at 4 months of age. †‡ 

Poliomyelitis 

(IPV) 

If the 1st dose of DTPa-containing vaccine 

was administered between >28 days and 

28 days and

Vaccine Minimum age 

for 1st dose 

in special 

circumstances* 

Action if a vaccine dose is inadvertently 

administered prior to the recommended 

minimum age 17 

Rotavirus 6 weeks If the 1st dose of rotavirus vaccine was 

administered at ≤28 days of age, it is 

recommended that the dose is repeated. 

This repeat dose should be given at 2 months 

of age. The NIP schedule should be followed 

thereafter, with the next dose of rotavirus vaccine 

given at 4 months of age. 

If the 1st dose of rotavirus vaccine was 

administered between >28 days and

* Special circumstances may include infants/children being vaccinated during an outbreak of a 

certain disease, before overseas travel, or opportunistic vaccination following early attendance 

to a provider. These ages will often differ from routinely recommended ages of administration 

under the NIP schedule. In some instances, these ages will also result in the dose not being 

considered by the Australian Childhood Immunisation Register (ACIR) as ‘valid’ for the purpose 

of calculating immunisation status. If the ACIR age requirement differs from the minimum ages 

in this table, this is noted. 

† If the need to repeat the 1st dose of vaccine is not recognised until the infant is older (e.g. a 

4-month-old infant presents for vaccination and has only previously received 1 dose of DTPahepB-IPV-Hib 

or 13vPCV vaccines both at age 28 days) of age. 17 

§ Monovalent hepatitis B vaccine should be given at birth (up to 7 days of age). However, for 

subsequent doses where hepatitis B-containing combination vaccine is given at 2, 4 and 6 months 

of age, the minimum age for the 1st dose (scheduled at age 2 months) is 6 weeks of age. If an 

infant has not received a birth dose within the first 7 days of life, a primary 3-dose course of a 

hepatitis B-containing combination vaccine should be given at 2, 4 and 6 months of age; catch-up 

of the birth dose is not necessary. 

MMRV vaccine is recommended as the 2nd (not 1st) dose of MMR-containing vaccine in 

children

Table 2.1.6: Number of vaccine doses that should have been administered by 

the current age of the child 

This table can be used in conjunction with Figure 2.1.1 Catch-up worksheet for children 

Table 2.1.7: Minimum acceptable dose intervals for children

Catch-up guidelines for individual vaccines for children

MMR vaccine, MMRV vaccine and varicella vaccine 

If no previous documented doses have been given, catch-up for MMR vaccine 

consists of 2 doses of MMR-containing vaccine, given at least 4 weeks apart 

(see 4.9 Measles). If no previous documented varicella vaccination has been 

given, a single dose of varicella-containing vaccine is recommended in children 

aged

If 13vPCV is not available, and 10vPCV is being used, 10vPCV is recommended 

in a 4-dose schedule. (See also 4.13 Pneumococcal disease.) If catch-up is required 

for 10vPCV, vaccination can be done according to the information provided in 

Table 2.1.10. 

Children aged ≥5 years who are not at increased risk of invasive pneumococcal 

disease (including Indigenous children aged ≥5 years) do not require catch-up 

doses of PCV. 

Preterm infants born at

Table 2.1.8: Catch-up schedule for Haemophilus influenzae type b (Hib) 

vaccination for children

Previous 

vaccination 

history 

2 previous 

doses of 

PRP-T 

(or 

1 of each of 

PRP-OMP and 

PRP-T) 

3 previous 

doses 

(all PRP-T or 

at least 1 PRP- 

OMP) 

Age at Type 

presentation of Hib 

vaccine to 

be used † 

7–11 months PRP-OMP 

or PRP-T 


or PRP-T 


or PRP-T 


or PRP-T 

1st 

dose 

Previously 

given 

Previously 

given 

Previously 

given 

Previously 

given 

2nd 

dose 

Previously 

given 

Previously 

given at 

≤15 months 

of age ‡ 

Previously 

given 

Previously 

given 

3rd 

dose 

Give 

now § 

Not 

needed 

Previously 

given 

Previously 

given at 

≤15 months 

of age ‡ 

Booster 

dose 

12 months 

of age or 

2 months 

after 2nd dose 

(whichever is 

later) 

Give now ‡ 

or 2 months 


(whichever is 

later) 

12 months 

of age or 

2 months 


(whichever is 

later) 

Give now ‡ 

or 2 months 


(whichever is 

later) 

* Recommendations for vaccination of haematopoietic stem cell transplant (HSCT) recipients 

differ; see Table 3.3.3 Recommendations for revaccination following HSCT in children and adults, 

irrespective of previous immunisation history. 

† PRP-OMP is the Hib formulation contained in Liquid PedvaxHIB. PRP-T is the Hib formulation 

contained in the other Hib-containing vaccines: ACT-Hib, Hiberix, Infanrix hexa, Menitorix 

and Pediacel. A minimum interval of 1 month is recommended between primary doses of Hibcontaining 

vaccine in a catch-up schedule. 

‡ A booster dose is not needed if the last previous dose was given at >15 months of age. 

§ If the 1st dose of Hib vaccine was given at >6 months of age, a 3rd dose, prior to the booster 

dose at age ≥12 months, is not required. 


2.1 PRE-VACCINATION


Table 2.1.9: Catch-up schedule for 13vPCV (Prevenar 13) for non-Indigenous children, and Indigenous children residing 

in the Australian Capital Territory, New South Wales, Tasmania and Victoria, who do not have any medical 

condition(s) associated with an increased risk of invasive pneumococcal disease (IPD), aged


Table 2.1.10: Catch-up schedule for 13vPCV* (Prevenar 13) for Indigenous children residing in the Northern Territory, 

Queensland, South Australia or Western Australia ONLY, who do not have any medical condition(s) associated 

with an increased risk of invasive pneumococcal disease (IPD), aged


Number of doses 

given previously 

2 previous doses 

3 previous doses 

Age at 

presentation 


Table 2.1.11: Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s) 

associated with an increased risk of invasive pneumococcal disease (IPD),* presenting at age


Number of 

doses given 

previously 

2 previous 

doses 

3 previous 

doses 

Age at 

presentation 

Age when previous dose of any PCV ‡ was given Recommendations 

1st dose 2nd dose 3rd dose Number 

of further 

primary dose(s) 

of 13vPCV 

required § 

Number of 

booster doses 

of 13vPCV 

required at 

age ≥12months 

Number 

of doses 

of 23vPPV 

required at 

age 4–5 years 

Catch-up schedules for persons ≥10 years of age 

Catch-up is much less commonly required for this age group than for young 

children. Nevertheless, issues surrounding booster doses or revaccinations are 

common, particularly in adults. Persons who did not have natural infection 

as children but were not vaccinated remain at unnecessary risk of vaccinepreventable 

diseases. 

In general, the same principles for catch-up vaccination apply as for younger 

children. For example, if a vaccine course is incomplete, do not start the course 

again, regardless of the interval since the last dose. One exception to this rule is 

for oral cholera vaccine (see 4.1 Cholera). 

Catch-up vaccination for adults can be less straightforward than for children and 

adolescents. A useful principle to consider when planning which vaccines to give 

to adults is the HALO principle, which allows for assessment of vaccines needed 

depending on risk factors: 

• Health 

• Age 

• Lifestyle 

• Occupation 

The schedule for each individual adult may differ because of the risk factors 

identified when applying the HALO principle. Some examples of how the HALO 

principle can be used: 

• Health: the person to be vaccinated has a medical condition(s) that places 

them at increased risk of acquiring a particular vaccine-preventable disease 

or experiencing complications from that disease, for example, influenza. 

• Age: older age groups may require extra vaccines, such as influenza or 

pneumococcal vaccination, or certain age groups may be targeted for 

immunisation against a particular vaccine-preventable disease, such as HPV. 

Another example is young to middle-aged adults who may have missed out 

on vaccine doses due to schedule changes, such as the 2nd dose of MMR 

vaccine. 

• Lifestyle: the person may have missed vaccines because they moved location 

of residence, may require extra vaccines because they travel frequently, or 

have other lifestyle risk factors that increase their risk of acquiring a vaccinepreventable 

disease, for example, smoking or injecting drugs. 

• Occupation: the person may be employed in an occupation for which certain 

vaccines are recommended because of the increased risk of acquiring a 

vaccine-preventable disease and/or transmitting it to others, such as in 

healthcare or early childhood education and care. 

The HALO principle is also incorporated, to some extent, into questions used in 

the pre-vaccination screening checklist (see Tables 2.1.1 and 2.1.2). 


2.1 PRE-VACCINATION

Table 2.1.12 contains information on vaccine doses and intervals between doses 

for persons aged ≥10 years in whom catch-up vaccination is required. This table 

only contains information on vaccines that are recommended at a population 

level, and for which catch-up is required if doses have been missed earlier in 

life. The table does not include information on all vaccines required for adults. 

Recommended vaccines and catch-up vaccination that might be required when 

assessed using the HALO principle above and/or by using the pre-vaccination 

screening checklist (see Tables 2.1.1 and 2.1.2) are discussed in 3.3 Groups with 

special vaccination requirements. 

Table 2.1.12 can be used as follows: 

• determine how many doses of a particular vaccine a person should have 

received to be considered completely vaccinated (see ‘Doses required’ 

column) 

• deduct any previous doses of the vaccine from the number in the ‘Doses 

required’ column 

• check the appropriate ‘Minimum interval’ column to schedule further doses 

• refer to the relevant disease-specific chapter(s) in Part 4, 3.1 Vaccination for 

Aboriginal and Torres Strait Islander people, 3.2 Vaccination for international 

travel, and 3.3 Groups with special vaccination requirements, for additional 

recommendations, as required. 

For example, a 32-year-old woman (Age) is returning to nursing (Occupation) 

but has only ever had 1 dose of hepatitis B vaccine, 4 doses of the oral 

poliomyelitis vaccine, 1 dose of MMR vaccine and 2 doses of DTPw vaccine as a 

child and recently had a splenectomy (Health) following an accident. This person 

would require: 

• 1 dose of dTpa 

• 2 adult doses of hepatitis B; 1 dose given now and a further dose in 2 months 

• no further doses of poliomyelitis vaccine (is fully vaccinated against 

poliomyelitis) 

• 1 dose of MMR vaccine 

• 2 doses of varicella vaccine if non-immune; 1 dose given now and a further 

dose in 4 weeks 

• 1 dose of influenza vaccine, and 1 dose annually thereafter 

• pneumococcal vaccine: 1 dose of 13vPCV, followed by 23vPPV approximately 

2 months later (because of splenectomy) 

• 1 dose of Hib vaccine (because of splenectomy) 

• 2 doses of 4vMenCV; 1 dose given now and a further dose in 8 weeks 

(because of splenectomy). 


For additional details on these recommendations, see 3.3.7 Vaccination of persons 

at occupational risk; ‘Persons with functional or anatomical asplenia’ in 3.3.3 

Vaccination of immunocompromised persons, and relevant disease-specific chapters 

in Part 4. 

Where several vaccines are required for an adolescent or adult – for example, 

dTpa, hepatitis B and poliomyelitis vaccines – childhood combination vaccines 

(recommended for use in those

Vaccine Doses 

required 

Zoster vaccine 1 dose if aged 

≥60 years 


Minimum 

interval 

between 

dose 1 and 2 

Minimum 

interval 

between 

dose 2 and 3 

Not required Not required 

* One of the doses should be given as dTpa (or dTpa-IPV if poliomyelitis vaccination is also 

needed) and the course completed with dT. In the unlikely event that dT is not available, dTpa or 

dTpa-IPV may be used for all 3 primary doses but this is not routinely recommended as there are no 

data on the safety, immunogenicity or efficacy of dTpa for primary vaccination (see also 4.12 Pertussis). 

† For hepatitis B vaccine, the minimum interval between dose 1 and dose 3 is 4 months (see 4.5 

Hepatitis B). 

‡ 4vMenCV is indicated for those at increased risk of meningococcal disease; see recommendations 

in 4.10 Meningococcal disease and 3.3 Groups with special vaccination requirements). 

§ Varicella vaccine is recommended for all non-immune persons. At least 1 dose should be given 

to those aged

2.2 ADMINISTRATION OF VACCINES 

2.2.1 Occupational health and safety issues 

Standard occupational health and safety guidelines should always be followed 

during a vaccination. This will minimise the risk of needle-stick injury. 1 

Work practices should include the use of standard infection control precautions 

to minimise exposure to blood and body fluids (refer to National Health and 

Medical Research Council’s Australian guidelines for the prevention and control 

of infection in healthcare). 1 If exposure does occur, guidelines for post-exposure 

prophylaxis should be followed. Gloves are not routinely recommended for 

immunisation service providers, unless the person administering the vaccine is 

likely to come into contact with body fluids or has open lesions on the hands. 

A new, sterile, disposable syringe and needle must be used for each injection. 

Disposable needles and syringes must be discarded into a clearly labelled, 

puncture-proof, spill-proof container that meets Australian standards in order to 

prevent needle-stick injury or re-use. 1 Always keep sharps containers out of the 

reach of children. All immunisation service providers should be familiar with the 

handling and disposal of sharps according to the National Health and Medical 

Research Council’s Australian guidelines for the prevention and control of infection in 

healthcare. 1 

2.2.2 Equipment for vaccination 

Preparing for vaccination 

Depending on the vaccine(s) that are to be administered, and the age and size of 

the person to be vaccinated, decide on the appropriate injection site and route, 

and the injection equipment required (e.g. syringe size, needle length and gauge). 

The equipment chosen will vary depending on whether the vaccine is a 

reconstituted vaccine, a vaccine from an ampoule or vial, or a vaccine in a prefilled 

syringe. 

Equipment may include: 

• medical waste (sharps) container 

• vaccine, plus diluent if reconstitution is required 

• 2 or 3 mL syringe (unless vaccine is in pre-filled syringe) 

• appropriate drawing-up needle (19 or 21 gauge needle if required, to draw 

up through rubber bung and for reconstitution of vaccine) 

• appropriate injecting needle (see Table 2.2.2 Recommended needle size, length 

and angle for administering vaccines) 

• clean cotton wool and hypoallergenic tape to apply to injection site after 

vaccination 

• a rattle or noisy toy for distraction after the injection. 


2.2 ADMINISTRATION 

OF VACCINES

Preparing the vaccine 

• Ensure that the minimum/maximum thermometer displays temperatures 

within the +2°C to +8°C range before removing vaccine from the refrigerator. 

• Ensure that the correct vaccine is taken from the refrigerator and that it is 

within the expiry date. 

• Check that there is no particulate matter or colour change in the vaccine. 

• Ensure that the diluent container is not damaged and potentially 

contaminated. 

• Wash hands with soap and water or use a waterless alcohol-based hand rub. 2 

• Prepare the appropriate injection equipment for the vaccine to be 

administered. 

Injectable vaccines that do not require reconstitution 

• If the vaccine is in a vial, remove the cap carefully to maintain sterility of the 

rubber bung. There is no need to wipe the rubber bung of single-dose vials 

with an alcohol swab if it is visibly clean. If there is visible contamination, the 

bung should be cleaned with a single-use swab, allowing time to dry before 

drawing up the contents. 3 

• Use a 19 or 21 gauge needle to draw up the recommended dose through the 

bung (or through the top of the ampoule), if required. 

• Change the needle after drawing up from a vial with a rubber bung or 

ampoule, before giving the injection. If using a safety needle system, once 

the vaccine has been drawn up, draw back on the syringe to ensure as much 

vaccine as possible is removed from the tip of the needle, and then eliminate 

any air to the tip of the syringe without re-priming the needle. 

Injectable vaccines that require reconstitution 

• Reconstitute the vaccine as needed immediately before administration. 

• Use a sterile 21 gauge needle for reconstitution and a separate 23 or 25 

gauge needle, 25 mm in length, for administration of the vaccine in most 

circumstances. 

• Use only the diluent supplied with the vaccine; do not use sterile water for 

injection instead of a supplied diluent. Ensure that the diluent and vaccine 

are completely mixed. 4 

• Check reconstituted vaccines for signs of deterioration, such as a change in 

colour or clarity. 

• Administer reconstituted vaccines as soon as practicable after they have been 

reconstituted as they may deteriorate rapidly. Refer to individual vaccine 

product information for recommended times from vaccine reconstitution to 

administration. 


• Never freeze a vaccine after it has been reconstituted. 

For all injectable vaccines 

• Do not extrude small air bubbles through the needle for injection. However, 

in the rare instance of a large air bubble in a pre-filled syringe, first draw back 

on the needle to ensure no vaccine is expelled along with the air, and then 

expel the air through the needle, taking care not to prime the needle with any 

of the vaccine, as this can lead to increased local reaction. 

• Never mix other vaccines together in the one syringe (unless that is the 

manufacturer’s registered recommendation, e.g. Infanrix hexa). 4 

• Never mix a local anaesthetic with a vaccine. 4 

Vaccines in multi-dose vials 

Multi-dose vials are not routinely used in Australia. The current exception 

is bacille Calmette-Guérin (BCG) vaccine (see 4.20 Tuberculosis). Single-dose 

preparations are now available for all other vaccines currently on the NIP. 

However, where mass vaccination of a population is required, such as during the 

2009–2010 H1N1 influenza pandemic, multi-dose vials have some advantages 

over single-dose vaccines. The production of vaccines in multi-dose vials is more 

cost effective and can also mean that the vaccine takes less time to manufacture. 

Multi-dose vials also take up less storage room in a vaccine fridge. 5 

The primary risk with use of multi-dose vials is a breach in infection control 

through user error, for example, an unsterile needle is inserted into the vial 

or a contaminated syringe is re-used. It is recognised that there are multiple 

reports of instances of transmission of bacteria or blood-borne viruses through 

inappropriate use of multi-dose vials; however, the majority of these have been in 

high-risk settings such as haemodialysis units or with use of anaesthetics and did 

not involve immunisations. 

2.2.3 Route of administration 

Most vaccines available in Australia are given intramuscularly. Only a few 

vaccines are given subcutaneously, orally or intradermally. 

Rotavirus vaccines are only available for oral administration and must never 

be injected. 

Special training is required for intradermal administration, which is important 

for several vaccines (see 4.15 Q fever and 4.20 Tuberculosis). 

Table 2.2.1 summarises the route of administration for vaccines used in Australia. 



OF VACCINES


Table 2.2.1: Route of administration for vaccines used in Australia 

Intramuscular (IM) injection Subcutaneous (SC) injection IM or SC injection Intradermal Oral 

Diphtheria-tetanus vaccine (dT) Inactivated poliomyelitis 

Diphtheria-tetanus-acellular 

vaccine (IPV)* 

pertussis vaccine (DTPa and 

dTpa) 

DTPa- and dTpa-combination 

Quadrivalent meningococcal 

polysaccharide vaccine 

(4vMenPV) 

vaccines 

Varicella vaccine (VV) 

Hepatitis A vaccine and 

Japanese encephalitis vaccine 

Hepatitis A combination 

(Imojev) 

vaccines 

Q fever vaccine 

Hepatitis B vaccine and Hepatitis 

B combination vaccines 

Haemophilus influenzae type b 

(Hib) vaccine 

Human papillomavirus (HPV) 

vaccine 

IPV-containing combination 

vaccines* 

Japanese encephalitis vaccine 

(JEspect) 

10-valent pneumococcal 

conjugate vaccine (10vPCV) 


conjugate vaccine (13vPCV) 

Typhoid Vi polysaccharide 

vaccine 

‡ 

Influenza vaccine 

Measles-mumps-rubella 

vaccine (MMR) (M-M-R II 

only) 

Measles-mumps-rubellavaricella 

vaccine (MMRV) 

(ProQuad only) 

Zoster vaccine 

† 

Measles-mumps- rubella 

vaccine (MMR) (Priorix only) 

Measles-mumps-rubellavaricella 

vaccine (MMRV) 

(Priorix-tetra only) 


polysaccharide vaccine 

(23vPPV) † 

Influenza vaccine 

(Intanza only) 

Bacille Calmette-Guérin 

(BCG) vaccine 

Rabies vaccine (HDCV) 

Yellow fever vaccine 

‡ 

Q fever skin testing ‡ 

Rotavirus vaccine 

Cholera vaccine 

Typhoid vaccine


Intramuscular (IM) injection Subcutaneous (SC) injection IM or SC injection Intradermal Oral 

Meningococcal C conjugate 

vaccine (MenCCV) 

Quadrivalent meningococcal 

conjugate vaccine (4vMenCV) 

Rabies vaccine (PCECV) 

* IPV-containing combination vaccines are administered by IM injection; IPV (IPOL) is administered by SC injection. 

† The IM route is preferred to the SC route because it causes fewer local adverse events. 6,7 

‡ Q fever skin testing and BCG vaccine should be administered only by specially trained immunisation service providers. 


OF VACCINES

2.2.4 Preparation for vaccine administration 

Skin cleaning 

Provided the skin is visibly clean, there is no need to wipe it with an antiseptic 

(e.g. alcohol wipe). 3,8 If the immunisation service provider decides to clean the 

skin, or if the skin is visibly not clean, alcohol and other disinfecting agents must 

be allowed to dry before vaccine injection (to prevent inactivation of live vaccines 

and to reduce the likelihood of irritation at the injection site). 9 

Distraction techniques 

The routine use of distraction, relaxation and other measures have been shown to 

reduce distress and pain following vaccination in young children. 10-13 Reducing 

children’s distress may enhance parents’ timely attendance for subsequent 

vaccinations. 

Distraction measures that may decrease discomfort following vaccination in 

young children include: 10-13 

• swaddling and holding the infant securely (but not excessively) 

• shaking a noisy toy (for infants and very young children) 

• playing music 

• encouraging an older child to pretend to blow away the pain using a 

windmill toy or bubbles 

• breastfeeding the infant during administration of the vaccine. 

Discomfort may also be decreased by administering sweet-tasting fluid orally 

immediately before the injection (with parental consent). In infants, 15–25% 

sucrose drops have been used. 14 

Topical anaesthetic agents, including vapocoolant sprays, are available but, to 

be effective, must be applied at the correct time before vaccine administration. 

Topical anaesthetics, such as EMLA, are not recommended for routine use, but 

could be considered in a child with excessive fear or dislike of needles; they 

require application 30 to 60 minutes before an injection. 15 

Vapocoolant sprays are applied 15 seconds before vaccination. These sprays have 

been shown to be more effective in adults than children as children can perceive 

coldness as painful and spray application may also focus the child more on the 

procedure. Topical lignocaine/prilocaine is not recommended for children 

2.2.5 Vaccine injection techniques 

Intramuscular injection technique 16,17 

• For intramuscular (IM) injection, use a 25 mm needle in most cases 

(see Table 2.2.2). 

• Depending on the injection site, position the limb so as to relax the muscle 

into which the vaccine is to be injected. 

• Pierce the skin at an angle of 90° to the skin, so the needle can be safely 

inserted to the hub. 18 Provided an injection angle of >70° is used, the needle 

should reach the muscle layer. 19 

• If using a 25 gauge needle for an IM vaccination, ensure the vaccine is 

injected slowly over a count of 5 seconds to avoid injection pain and muscle 

trauma (see Table 2.2.2). 

• If you have drawn back on the syringe plunger before injecting a vaccine 

(which is not considered necessary), 10 and a flash of blood appears in the 

needle hub, withdraw the needle and select a new site for injection. 20 

Studies have demonstrated that, for most vaccines, local adverse events 

are minimised and immunogenicity is enhanced by ensuring vaccine is 

deposited into the muscle and not into the subcutaneous layer. 10,21-24 However, 

some vaccines (e.g. inactivated poliomyelitis, varicella and meningococcal 

polysaccharide vaccines) are only registered for SC administration (see Table 

2.2.1). 

In the instance where a vaccine that is registered for administration only via 

the IM route is inadvertently administered via the SC route, check the vaccine 

product information and the ‘Vaccines’ section in relevant disease-specific 

chapters in Part 4 for additional information. Some vaccines may still be 

immunogenic when given via the SC route, and as such, would not need to 

be repeated. One vaccine that should be considered invalid and that therefore 

needs to be repeated is Rabipur Inactivated Rabies Virus Vaccine (PCECV) (see 

4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus)). In general, 

hepatitis B vaccines should also be repeated if inadvertently given SC. However, 

in special circumstances, for example, in persons with bleeding disorders, some 

hepatitis B vaccines may be given via the SC route (see 3.3.5 Vaccination of persons 

with bleeding disorders). 

A clinical trial demonstrated that for infant vaccination long (25 mm) needles 

(with the skin stretched flat and the needle inserted at 90°) were associated 

with significantly fewer local adverse events, while achieving comparable 

immunogenicity. Little difference in local adverse events or immune response 

was found between needles of the same length but with different gauges. 18 



OF VACCINES

Subcutaneous injection technique 

For subcutaneous (SC) injection, administer the injection at a 45° angle to the 

skin. The standard needle for administering vaccines by SC injection is a 25 or 26 

gauge needle, 16 mm in length. 

The immune response to vaccines inadvertently given IM rather than SC is 

unlikely to be affected. Therefore it is usually not necessary to repeat doses in this 

instance. 

Intradermal injection technique 

For intradermal injection of BCG vaccine or Q fever skin test, a 26 or 27 gauge, 

10 mm needle is recommended. The intradermal injection technique requires 

special training, and should be performed only by a trained provider (see 4.20 

Tuberculosis and 4.15 Q fever). 

One brand of influenza vaccine (Intanza) is administered via the intradermal 

route. This vaccine is presented with a specifically designed needle and 

syringe called the Micro-Injection System and will deliver the 0.1 mL dose of 

vaccine into the dermal layer of the skin without the need for special training. 

Manufacturer’s instructions in the product packaging should be followed for 

correct administration. 

Table 2.2.2: Recommended needle size, length and angle for administering 

vaccines 10,16,18,21,25 

Age or size of child/adult Needle type Angle of needle 

insertion 

Infant, child or adult for IM vaccines 

Preterm babies (

Interruption to a vaccination 

If the process of administration of a vaccine given parenterally (IM or SC) is 

interrupted (e.g. by syringe–needle disconnection) and most of the dose has not 

been administered, the whole dose should be repeated as soon as practicable. 

If most of an oral rotavirus vaccine dose has been spat out or vomited within 

minutes of administration, a single repeat dose can be administered during 

the same visit. If an infant regurgitates or vomits only a small part of a dose 

of oral rotavirus vaccine, it is not necessary to repeat the dose. Therefore, the 

regurgitated (and incomplete volume) dose is still considered as the valid dose 

(see 4.17 Rotavirus). 

2.2.6 Recommended injection sites 

The choice of injection sites depends primarily on the age of the person to be 

vaccinated. The two anatomical sites recommended as routine injection sites are 

the anterolateral thigh (Figures 2.2.5 and 2.2.6) and the deltoid muscle (Figure 

2.2.8). Immunisation service providers should ensure that they are familiar 

with the landmarks used to identify any anatomical sites used for vaccination. 

Photographs and diagrams are provided in this section, but are not a substitute 

for training. Further detail on identifying the recommended injection sites is 

provided in 2.2.8 Identifying the injection site. 

Infants

ut, if this site is used, the less locally reactogenic vaccines (e.g. MMR) should be 

given in the thigh. 

Children with congenital limb malformation or children in spica casts 

Children with congenital limb malformation(s) should receive their vaccines in 

an unaffected limb where possible. The ventrogluteal area can also be considered 

(see Figure 2.2.7 in 2.2.8 Identifying the injection site). 29 

Administration of vaccines to children in spica casts can be timed to occur when 

the cast is being changed. Parents should be informed of the importance of looking 

for any signs of swelling that may compromise circulation and, if this occurs, 

to seek advice from their physiotherapist or doctor as soon as possible. 29 Some 

resources suggest the use of the deltoid muscle as an alternative route for children 

in spica casts. If using this site, it is important to be aware of the radial nerve, 

which is located superficially near the deltoid in children

2.2.7 Positioning for vaccination 

It is important that infants and children do not move during injection of vaccines. 

However, excessive restraint can increase their fear and result in increased 

muscle tension. The following section describes a variety of positions that may be 

used for vaccinating different age groups. 

Infants

Positioning an infant on an examination table 

An alternative is to lay an infant on his/her back on an examination table, with 

the infant’s feet towards the immunisation service provider, and the parent/carer 

beside the provider to immobilise and distract the baby (see Figure 2.2.2). 

Keep the infant’s hip and knee flexed by cupping the patella in the non-injecting 

hand. 

The thumb and index finger of the non-injecting hand may be used to stabilise 

the hub of the needle once the needle has been inserted. 

Although the exact mechanism is unclear, recent studies have shown that placing 

a child in the supine position may result in more pain than if the child is held in 

an upright position. 15 

Figure 2.2.2: Positioning an infant on an examination table for vaccination 

Photo courtesy Dr Joanne Molloy, Victoria 

Prone position across the lap for ventrogluteal vaccination 

For ventrogluteal injection, position the child face-down across the parent/ 

carer’s lap (see Figure 2.2.7 below). This allows the hips to be flexed and provides 

access to the ventrogluteal area. 


Children ≥12 months of age 

Cuddle position for an older child 

Sit the child sideways on the lap of the parent/carer, with the arm to be injected 

held close to the child’s body while the other arm is tucked under the armpit and 

behind the back of the parent/carer. 

The child’s exposed arm should be secured at the elbow by the parent/carer, and 

the child’s legs should also be secured by the parent/carer (see Figure 2.2.3). 

Figure 2.2.3: Positioning an older child in the cuddle position 

Photo courtesy CHW Photography 

Straddle position 

An older child may be positioned facing the parent/carer with the legs straddled 

over the parent/carer’s lap. The child’s arms should be folded in front, with the 

parent/carer hugging the child’s body to the parent/carer’s chest. Alternatively 

the child may be positioned to ‘hug’ the parent/carer with the parent/carer’s 

arms holding the child’s arms in a reciprocal hug (see Figure 2.2.4). This position 

allows access to both deltoids and both anterolateral thighs. 



OF VACCINES

Figure 2.2.4: Positioning a child in the straddle position 

Photo courtesy CHW photography 

Prone position across the lap for ventrogluteal vaccination 

For ventrogluteal injection, position the child face-down across the parent/ 

carer’s lap (see Figure 2.2.7 below). 

Older children, adolescents and adults 

Solo sitting position for deltoid injections 

Most vaccines can be administered into the deltoid area. Adults should sit in 

a straight-backed chair, feet resting flat on the floor with forearms and hands 

in a relaxed position on the upper thighs. Keep the arms flexed at the elbow to 

encourage the deltoid muscle to relax. 

Encourage the shoulders to drop by asking the person to raise the shoulders 

up while taking a deep breath in and to drop them while breathing out fairly 

forcefully. Use distraction to keep muscles relaxed during the procedure, for 

example, have an interesting poster or similar for the person to concentrate on 

during the procedure and ask him/her to give you a detailed description of what 

can be seen. 

The ventrogluteal and vastus lateralis are alternative sites if needed (see 2.2.6 

Recommended injection sites and 2.2.8 Identifying the injection site). 


2.2.8 Identifying the injection site 

The choice of injection site depends on the age of the person to be vaccinated, 

and is discussed in 2.2.6 Recommended injection sites. 

The anterolateral thigh (vastus lateralis) 

• Make sure the infant’s nappy is undone to ensure the injection site is 

completely exposed and the anatomical markers can be easily identified by 

sight and palpation. 

• Position the leg so that the hip and knee are flexed and the vastus lateralis is 

relaxed (see Figure 2.2.6). 

• Identify the following anatomical markers: the upper marker is the midpoint 

between the anterior superior iliac spine and the pubic tubercle, and the 

lower marker is the upper part of the patella. 

• Draw an imaginary line between the two markers down the front of the 

thigh. The correct site for IM vaccination is lateral to the midpoint of this line, 

in the outer (anterolateral) aspect (see Figures 2.2.5 and 2.2.6). 

• Do not inject into the anterior aspect of the thigh where neurovascular 

structures can be damaged. 

Figure 2.2.5 Anatomical markers used to identify the vastus lateralis injection 

site (X) on the anterolateral thigh 

Level of greater 

trochanter 

Level of lateral 

femoral condyle 

Tensor fascia lata 

Injection site 

llio-tibial tract 

x 

Anterior superior 

iliac spine 

Pubic tubercle 

Femoral artery 

and vein 

Sartorius 

Rectus femoris 

Vastus lateralis 

Patella 



OF VACCINES

Figure 2.2.6: The vastus lateralis injection site (X) on the anterolateral thigh 

Photo courtesy Lloyd Ellis, The Royal Children’s Hospital, Victoria 

The ventrogluteal area 

Note: This area should not be confused with the dorsogluteal area (buttock). 

The ventrogluteal area provides an alternative site for administering vaccines 

to a child of any age, especially when multiple injections at the same visit are 

required. The ventrogluteal area is relatively free of major nerves and blood 

vessels, and the area provides the greatest thickness of gluteal muscle. 35,36 There is 

a relatively consistent thinness of subcutaneous tissue over the injection site. 36,37 

• Make sure the child’s nappy is undone to ensure the injection site is 

completely exposed and the anatomical markers can be easily identified by 

sight and palpation. Anatomical markers are the anterior superior iliac spine 

(ASIS), the greater trochanter of the femur and the iliac crest (see Figure 

2.2.7). 

• Place the child in a prone position (face-down) on the parent/carer’s lap 

or on the clinic table/bed, with the child’s arms tucked against their chest. 

Allow the child’s legs to dangle towards the floor (see Figure 2.2.7). 

• Ensure the knee and hip are turned inwards to encourage muscle relaxation 

at the injection site. 

• Use the injection site that is closest to you. 


• Place the palm over the greater trochanter (the uppermost bony prominence 

of the thigh bone), with the thumb pointing towards the umbilicus. Point 

the index finger towards the anterior superior iliac spine, and spread the 

middle finger so it aims at the iliac crest, thus creating a ‘V’ outlining the 

ventrogluteal triangular area. The injection site is at the centre of this area 

(see Figure 2.2.7). 

Figure 2.2.7: Anatomical markers used to identify the ventrogluteal injection 

site (X) 

ASIS = anterior superior iliac spine 

Photo courtesy of Dr Joanne Molloy, Victoria 

The deltoid area 

To locate the deltoid site for injection: 

• Expose the arm completely, from the top of the shoulder to the elbow; roll up 

the sleeve or remove the shirt if needed. 

• Locate the shoulder tip (acromion) and the muscle insertion at the middle of 

the humerus (deltoid tuberosity). 

• Draw an imaginary inverted triangle below the shoulder tip, using the 

identified anatomical markers (see Figure 2.2.8). 

The deltoid site for injection is halfway between the acromion and the deltoid 

tuberosity, in the middle of the muscle (triangle). 



OF VACCINES

Figure 2.2.8: Anatomical markers used to identify the deltoid injection site 

Subcutaneous injection sites 

Subcutaneous injections should be administered either over the deltoid muscle 

or over the anterolateral thigh. There are no studies that describe any specific 

differences in the technique used for an ‘SC injection’ compared with a ‘deep 

SC injection’. Figure 2.2.9 demonstrates the recommended technique for any SC 

injection. 

Figure 2.2.9: A subcutaneous injection into the deltoid area of the upper arm 

using a 25 gauge, 16 mm needle, inserted at a 45° angle 

Photo courtesy Jane Jelfs NCIRS 


2.2.9 Administering multiple vaccine injections at the same visit 

When sequentially administering multiple vaccines to children, give the most 

painful vaccine last (e.g. pneumococcal conjugate vaccine). Evidence suggests 

that this may decrease the overall pain response. 

The location of each separate injection given should be recorded, so that if a local 

adverse event occurs, the implicated vaccine(s) can be identified. 

Infants

• If the deltoid muscle mass is small: 

» give further injections into either anterolateral thigh (2.5 cm apart if two 

vaccines are given in the same thigh), or 

» give one injection into each ventrogluteal area. 

For younger children, the cuddle or straddle positions (Figures 2.2.3 and 2.2.4) 

are suitable for accessing multiple limbs during the one vaccination encounter. 

Simultaneous injections by two immunisation providers 

Currently there is insufficient evidence for or against having two immunisation 

providers administer vaccines at the same time rather than one vaccine after the 

other. 38,39 Two studies were unable to demonstrate a difference in pain response in 

the child between simultaneous administration and sequential administration. 38,39 

If multiple immunisation providers are available, the technique has been 

explained to the parent and the parent gives consent, then the vaccines may be 

administered simultaneously, providing different sites can be safely accessed. 

References 




2.3 POST-VACCINATION 

2.3.1 Immediate after-care 

Immediately after vaccine administration: 

• dispose of clinical waste, including sharps and vaccine vials, at the point of 

use (refer to state/territory health authorities for management guidelines for 

the safe disposal of clinical waste or refer to the National Health and Medical 

Research Council’s Australian guidelines for the prevention and control of infection 

in healthcare) 1 

• cover the injection site quickly with a dry cotton ball and tape as needed 

• gently apply pressure for 1 or 2 minutes – do not rub the site as this will 

encourage the vaccine to leak back up the needle track, which can cause pain 

and may lead to local irritation 

• to distract the vaccinated person and reduce distress, immediately change the 

position of the child/person after completing the vaccination, for example, 

ask the parent/carer to put the infant over his/her shoulder and move 

around with the infant2 • remove the cotton wool after a few minutes and leave the injection site 

exposed to the air 

• record the relevant details of the vaccines given (see 2.3.3 Documentation of 

vaccination). 

The vaccinated person and/or parent/carer should be advised to remain in the 

vicinity for a minimum of 15 minutes after the vaccination. The area should be 

close enough to the immunisation service provider so that the vaccinated person 

can be observed and medical treatment provided rapidly if needed. 

Paracetamol is not routinely used before, or at the time of, vaccination, but may 

be recommended as required for fever or pain occurring following immunisation. 

Before departure, inform the vaccinated person or parent/carer, preferably in 

writing, of any expected adverse events following immunisation, and of the date 

of the next scheduled vaccination(s). 

Take the opportunity to check the vaccination status of other family members 

(as appropriate) and discuss any catch-up vaccination requirements and options 

available (this can also be done earlier in the visit). 

2.3.2 Adverse events following immunisation 

What are adverse events following immunisation? 

An adverse event following immunisation (AEFI) is any untoward medical 

occurrence that follows immunisation and does not necessarily have a causal 

relationship with the usage of the vaccine. The adverse event may be any 

unfavourable or unintended sign, abnormal laboratory finding, symptom or 

disease. 3 Such an event may be caused by the vaccine(s) or may occur by chance 


2.3 POST-VACCINATION

(i.e. it would have occurred regardless of vaccination). Most vaccine adverse 

events are minor, such as low-grade fever, and pain or redness at the injection 

site; these should be anticipated. 4 The frequency of adverse events has been 

classified by regulatory agencies, and is often reported in clinical trials as follows: 

very common (>10% of persons vaccinated), common (1–10%), uncommon (0.1– 

Management of an immediate adverse event following immunisation 

The vaccinated person should remain under observation for a short interval 

to ensure that they do not experience an immediate adverse event. It is 

recommended that vaccinated persons remain in the vicinity of the place of 

vaccination for at least 15 minutes. Severe anaphylactic reactions usually have 

a rapid onset; life-threatening adverse events are most likely to begin within 15 

minutes of vaccination. 

The most serious immediate AEFI is anaphylaxis. However, in adults and older 

children, the most common immediate adverse event is a vasovagal episode 

(fainting), either immediately or soon after vaccination. Because fainting 

after vaccination can lead to serious consequences, anyone who complains of 

giddiness or light-headedness before or after vaccination should be advised to lie 

down until free of symptoms. 

Anaphylaxis and vasovagal episodes 

Anaphylaxis following routine vaccination is very rare, but can be fatal. 6 All 

immunisation service providers must be able to recognise all the symptoms 

and signs of anaphylaxis and distinguish between anaphylaxis, convulsions 

and fainting. The features listed in Table 2.3.1 may be useful in differentiating 

between fainting (vasovagal episode) and anaphylaxis. 

Anaphylaxis is a severe adverse event of rapid onset, characterised by 

sudden respiratory compromise and/or circulatory collapse. 7 Early signs 

include involvement of the skin (e.g. generalised erythema, urticaria and/or 

angioedema) and/or gastrointestinal tract (e.g. diarrhoea, vomiting). In severe 

cases, there is circulatory collapse with alteration in the level of consciousness, 

hypotension and weak or absent pulses, and/or marked respiratory compromise 

from upper airway oedema or bronchospasm. 

Fainting (vasovagal episode) is relatively common after vaccination of adults and 

adolescents, but infants and children rarely faint. Sudden loss of consciousness 

in young children should be presumed to be anaphylaxis, particularly if a strong 

central pulse is absent. A strong central pulse (e.g. carotid) persists during a faint 

or convulsion. 

If a diagnosis of anaphylaxis is suspected, treatment, including administration 

of adrenaline, should be instituted promptly8 (see ‘Management of anaphylaxis’ 

below). Under-treatment of anaphylaxis is more harmful, and potentially lifethreatening, 

than over-treatment of a mild or moderate allergic reaction. 9 



Table 2.3.1: Clinical features that may assist differentiation between a 

vasovagal episode and anaphylaxis 

Vasovagal 

episode 

Onset Immediate, 

usually within 

minutes of, or 

during, vaccine 

administration 

Symptoms/ 

Signs 

Respiratory Normal 

respiration; may 

be shallow, but 

not laboured 

Cardiovascular Bradycardia, 

weak/absent 

peripheral pulse, 

strong carotid 

pulse 

Hypotension – 

usually transient 

and corrects in 

supine position 

Loss of 

consciousness 

– improves 

once supine or 

in head-down 

position 

Skin Generalised 

pallor, cool, 

clammy skin 

Gastrointestinal Nausea/ 

vomiting 

Neurological † Feels faint, lightheaded 


Anaphylaxis* 

Usually within 15 minutes, 

but can occur within hours, of 

vaccine administration 

Cough, wheeze, hoarseness, 

stridor, or signs of respiratory 

distress (e.g. tachypnoea, 

cyanosis, rib recession) 

Upper airway swelling (lip, 

tongue, throat, uvula or larynx) 

Tachycardia, weak/absent 

carotid pulse 

Hypotension – sustained and 

no improvement without 

specific treatment (Note: in 

infants and young children, 

limpness and pallor are signs 

of hypotension) 

Loss of consciousness – no 

improvement once supine or in 

head-down position 

Pruritus (skin itchiness), 

generalised skin erythema 

(redness), urticaria (weals) 

or angioedema (localised 

or general swelling of the 

deeper layers of the skin or 

subcutaneous tissues) 

Abdominal cramps, diarrhoea, 

nausea and/or vomiting 

Sense of severe anxiety and 

distress 

* Modified from The Brighton Collaboration Case Definition Criteria for Anaphylaxis. 6 

† Neurological symptoms are not listed in the Brighton case definition criteria for anaphylaxis; 6 

however, symptoms of anxiety and distress, including feelings of impending doom, are reported 

in persons experiencing anaphylaxis. 7,10

Management of anaphylaxis 

Rapid IM administration of adrenaline is the cornerstone of treatment of 

anaphylaxis. Adrenaline is life saving and must be used promptly. 8 

Anaphylaxis occurs without warning, usually within 15 minutes of giving a 

vaccine. A protocol for the management of anaphylaxis, adrenaline and 1 mL 

syringes must always be immediately at hand whenever vaccines are given. 

• If the patient is unconscious, lie him/her on the left side and position to keep 

the airway clear. 

• If the patient is conscious, lie him/her supine in ‘head-down and feet-up’ 

position (unless this results in breathing difficulties). 

• If there are any respiratory and/or cardiovascular symptoms or signs of 

anaphylaxis, give adrenaline by IM injection into the anterolateral thigh 

(see ‘Use of adrenaline’ below for dosage). Adrenaline is not required for 

generalised non-anaphylactic reactions (such as skin rash or angioedema). 

If in doubt, IM adrenaline should be given. No serious or permanent harm 

is likely to occur from mistakenly administering adrenaline to an individual 

who is not experiencing anaphylaxis. 11 

• Call for assistance. Never leave the patient alone. 

• If oxygen is available, administer by facemask at a high flow rate. 

• If there is no improvement in the patient’s condition within 5 minutes, repeat 

doses of adrenaline every 5 minutes until improvement occurs. 

• Check breathing; if absent, commence basic life support or appropriate 

cardiopulmonary resuscitation (CPR), as per the Australian Resuscitation 

Council guideline12 (available at www.resus.org.au/policy/guidelines). 

• In all cases, transfer the person to hospital for further observation and 

treatment. 

• Complete full documentation of the event, including the time and dose(s) of 

adrenaline given. 

Antihistamines and/or hydrocortisone are not recommended for the emergency 

management of anaphylaxis. 

Use of adrenaline 

The use of 1:1000 adrenaline is recommended because it is universally available. 

Adrenaline 1:1000 (one in one thousand) contains 1 mg of adrenaline per mL of 

solution in a 1 mL glass vial. Adrenaline 1 in 10 000 is no longer recommended 

for the treatment of anaphylaxis. A 1 mL syringe should be used to improve the 

accuracy of measurement when drawing up small doses of adrenaline. 

The recommended dose of 1:1000 adrenaline is 0.01 mL/kg body weight 

(equivalent to 0.01 mg/kg or 10 µg/kg) up to a maximum of 0.5 mL, given by 

deep IM injection preferably in the anterolateral (upper outer) thigh. The anterolateral 

thigh is the preferred site because there is a more predictable dispersal of 



adrenaline from this site. 13 Administration of adrenaline in the anterolateral 

thigh is also in accordance with recommendations from various emergency 

medicine, anaesthetic and immunology professional bodies. 9 

Adrenaline 1:1000 must not be administered intravenously. 

Table 2.3.2 lists the dose of 1:1000 adrenaline to be used if the exact weight of 

the person is not known. 

The dose of 1:1000 (one in one thousand) adrenaline may be repeated every 

5 minutes, as necessary, until there is clinical improvement. 

Table 2.3.2: Doses of intramuscular 1:1000 (one in one thousand) adrenaline for 

anaphylaxis* 14 

Approximate age and weight Adrenaline dose 

12 years and adult (over 50 kg) 0.5 mL 

* Modified from insert published in Australian Prescriber 14 (available at www.australianprescriber. 

com/magazine/34/4/article/1210.pdf). Endorsed by the Australasian Society of Clinical 

Immunology and Allergy, the Royal Australasian College of Physicians, the Royal Australian 

College of General Practitioners, the Australasian College for Emergency Medicine, the Royal 

Australian and New Zealand College of Radiologists, the Internal Medicine Society of Australia 

and New Zealand, and the Australian Dental Association. 

Use of adrenaline autoinjectors for anaphylaxis treatment 

Adrenaline autoinjectors, EpiPen or Anapen, are devices that administer a single, 

pre-measured dose of adrenaline. They are designed for use by any person, 

whether medically trained or not. Clear instructions on correct use are provided 

on the barrel and in the packaging of these devices. They are designed to be 

administered in the mid-outer thigh. 

Autoinjectors are usually recommended or prescribed for an individual who is 

at risk of anaphylaxis due to an existing allergy or where skin testing indicates 

a high risk of an allergic reaction on exposure to an allergen. If a patient who 

carries an autoinjector device develops anaphylaxis post vaccination, it is 

appropriate to use their autoinjector to administer adrenaline. 


Autoinjectors are generally not appropriate for inclusion in first aid kits for 

general use, due to several limitations: 

• they are single-use only 

• they are dose-specific 

» EpiPen Jr or Anapen Jr containing 150 µg of adrenaline are recommended 

for children weighing between 10 kg and 20 kg 

» EpiPen or Anapen containing 300 µg of adrenaline are recommended for 

children and adults weighing over 20 kg 

• multiple pens would be required to allow for repeat dosing and varying 

ages/weights of patients, and shelf-life is limited to 1 to 2 years maximum. 

Autoinjectors are not recommended for use in children weighing less than 10 kg. 

Common adverse events following immunisation and their management 

Commonly occurring AEFI are described in the table Comparison of the effects of 

diseases and the side effects of NIP vaccines inside the back cover of this Handbook 

and in the disease-specific chapters in Part 4. 

The most commonly encountered adverse events are local reactions related to 

vaccine injection(s), such as pain, redness, itching, swelling or burning at the 

injection site. These are to be expected, are generally mild and usually last for 

1 to 2 days. Injection site nodules are also relatively common. They are fibrous 

remnants of the body’s interaction with the vaccine components (usually an 

adjuvant) in the muscle. They may remain for many weeks after vaccination and 

do not require any specific treatment. 

Low-grade fever and tiredness (malaise), lasting a few days, are also common 

after many vaccines. These responses are usually mild and self-limiting, and 

generally do not require specific treatment. 

Routine use of paracetamol at the time of, or immediately after, vaccination is 

not recommended. However, if an infant, child or adult has a fever of >38.5°C 

following vaccination or has pain at the injection site, paracetamol can be given. 

The dose of paracetamol for an infant or child up to 12 years of age is 

15 mg/kg/dose, up to a maximum dose of 60 mg/kg per day in four divided 

doses. Adults and children aged ≥12 years can receive 500 to 1000 mg every 4 to 6 

hours; dosage must not exceed 4 g in 24 hours. Paracetamol should not be given 

for more than 48 hours without seeking medical advice. 15 

If patients exhibit unexpected, serious or prolonged adverse symptoms or signs 

following immunisation, medical advice should be sought. The symptoms and 

signs from medical illness unrelated to vaccination can sometimes be attributed 

to a recent immunisation and should be investigated and managed accordingly. 



Uncommon/rare adverse events following immunisation 

Some vaccines have been shown to cause uncommon or rare serious adverse 

events, although the rate of vaccine adverse events is usually hundreds to 

thousands times less frequent than the disease complications. Information on the 

benefits compared with risks of immunisation is always taken into account when 

making recommendations for vaccine use. It is important to provide persons 

to be vaccinated or their parent/carer with advice regarding known, but rare, 

adverse events following immunisation, and to place the advice in the context of 

the benefits of vaccination (see 3.3.1 Vaccination of persons who have had an adverse 

event following immunisation). 

If a patient has experienced a serious or uncommon/rare AEFI, it is important 

that they or their immunisation service provider seek advice from a specialist 

immunisation clinic or contact state/territory health authorities for more 

information regarding the need for further investigation and management (see 

Appendix 1 Contact details for Australian, state and territory government health 

authorities and communicable disease control). This will enable an assessment to 

determine the relationship to vaccination, consideration of the benefits and risks 

of further vaccination, and planning for receiving additional doses of that or 

other vaccines, as appropriate. Persons who have had a serious adverse event 

following immunisation (other than a contraindication, such as the confirmed 

identity of the vaccine component that triggered anaphylaxis) can usually 

subsequently be vaccinated under close medical supervision. For more detailed 

information see 3.3.1 Vaccination of persons who have had an adverse event following 

immunisation. 

Examples of uncommon and rare adverse events are given below. It is important 

to remember that, although these events are uncommon or rare, they are still 

not necessarily causally related to vaccination, even if they occur following 

vaccination. 

• Febrile convulsions are a relatively common response to fever of any cause 

in young children, particularly in those aged

Australia. 16 This vaccine is no longer registered for use in this age group. An 

excess risk of fever and febrile convulsions was not observed with the other 

influenza vaccines given to children. 16,17 

• Brachial neuritis (inflammation of a nerve in the arm, causing weakness 

or numbness) has been described following the administration of tetanus 

toxoid-containing vaccines, with an estimated excess risk of approximately 

0.5–1 in 100 000 doses in adults. 5,18 Case reports of brachial neuritis following 

administration of other vaccines, including HPV vaccines, 19 are rare and a 

causal relationship has not been established. 20 

• Oral rotavirus vaccines are associated with a small increased risk of 

intussusception (IS), a rare form of bowel blockage caused by telescoping 

of the intestine into itself. This risk appears to be particularly in the 7 days 

following the 1st vaccine dose; however, a smaller increased risk in the week 

following the 2nd dose has also been reported. 21-23 It is not currently clear 

whether there is an overall increase in the risk of IS above that which would 

be expected in the 1st year of infancy without vaccine use. The increased risk 

represents approximately 6 additional cases of intussusception among every 

100 000 infants vaccinated, or 18 additional cases per year in Australia. 23 

Children who have had IS are recommended to not receive rotavirus vaccine 

(see 4.17 Rotavirus). 

• Anaphylaxis following receipt of vaccines has been reported, but generally 

occurs very rarely. 24 For example, the estimated incidence rate of anaphylaxis 

following 4vHPV vaccine in Australia as at June 2010 was 2.6 anaphylaxis 

episodes per million doses of vaccine distributed. 25 This is within the 

same rate range as for other vaccines given to children and adolescents in 

international studies, such as hepatitis B vaccine, which is associated with 

anaphylaxis in approximately 1 in 1.1 million doses distributed. 26 (For more 

information on the management of immediate AEFI/anaphylaxis, see above.) 

• Hypotonic-hyporesponsive episode (HHE) is the sudden onset of pallor 

or cyanosis, limpness (muscle hypotonia), and reduced responsiveness 

or unresponsiveness occurring after vaccination, where no other cause is 

evident such as a vasovagal episode or anaphylaxis. The episode usually 

occurs 1 to 48 hours after vaccination and resolves spontaneously. There are 

no known long-term side effects from HHE. 27,28 In Australia during 2009, 

3.2 cases of HHE were reported per 100 000 doses of DTPa-containing vaccine 

given to children

Events where evidence demonstrates no causal link with immunisation 

Since vaccines are mainly given to healthy people, a range of conditions that 

occur after a vaccine dose may be attributed to vaccination. This is particularly so 

for illnesses that are complex and have an unknown or unclear cause. As many 

of these illnesses are rare and/or manifest months to years after vaccination, 

they are difficult to study in randomised controlled clinical trials, which are 

typically conducted before vaccines are registered for use. However, there is 

strong epidemiological evidence, usually derived from multiple well-conducted 

post-marketing studies, that indicates there is no causal association between 

immunisation and many diseases/conditions in which vaccines were suggested 

to have been involved. 

Examples of events unrelated to vaccination include: 

• sudden infant death syndrome (SIDS) and any vaccine31-33 • autism and MMR vaccine34-39 • multiple sclerosis and hepatitis B vaccine40-43 • inflammatory bowel disease and MMR vaccine44 • diabetes and Hib vaccine45-47 • asthma and any vaccine. 48 

Despite this evidence, patients/parents seeking further advice should discuss 

this with their immunisation provider or could be referred to a specialist 

immunisation clinic for further reassurance (see Appendix 1 Contact details 



Reporting adverse events following immunisation 

Surveillance for adverse events following immunisation is an integral part 

of the Australian National Immunisation Program, and underpins the safe 

use of all vaccines in Australia. Surveillance of AEFI aims to detect changes 

in the rates of known adverse events, any unrecognised or unexpected 

adverse events, or adverse events that result from program errors, such as 

incorrect vaccine schedule, delivery or storage. It is very important that 

all immunisation service providers report AEFI, particularly if serious or 

unexpected, as this will enable vaccine safety issues to be identified and 

managed appropriately as soon as possible. For example, reporting of AEFI by 

immunisation service providers in Australia in 2010 resulted in the detection of 

an unexpectedly high rate of fever and febrile convulsions in young children, 

associated with the use of one brand of seasonal influenza vaccine. 49,50 All 

reported AEFI are included in the Adverse Drug Reactions System (ADRS) 

database of the Therapeutic Goods Administration (TGA). For details on how 

to report AEFI, see the next section below. 


Any serious or unexpected adverse event following immunisation should 

be promptly reported. Providers should use clinical judgment in deciding 

which adverse events to report and parents/carers should be encouraged 

to notify the immunisation service provider or health authorities of any 

untoward medical occurrence that follows immunisastion. 

No time limit has been set to report AEFI; however, timely notification of adverse 

events, particularly rapid reporting of serious events, is important to identify any 

potential concerns. Notification does not necessarily imply a causal association 

with vaccination, as some events may occur coincidentally following vaccination. 

Any event that is suspected of being related to vaccination can be reported. 

All identifying information relating to the reporter and patient is kept strictly 

confidential. Any person, medical or non-medical, including providers who did 

not give the vaccine(s), can report an AEFI; however, it is very important that as 

much detail as possible is provided on all reports. 

In addition to reporting of AEFI, immunisation service providers may need 

to provide additional clinical management and advice regarding future 

vaccination(s) for their patient and may require expert advice. Information about 

specialist immunisation clinics, or the contact details for paediatricians or medical 

specialists with experience in management of patients with AEFI, are usually 

available from state and territory health authorities (see Appendix 1 Contact details 


disease control) and from the Immunise Australia website (www.immunise.health. 

gov.au). For more information on managing common and rare AEFI, 

see above and also 3.3.1 Vaccination of persons who have had an adverse event 

following immunisation. 

How to report adverse events following immunisation 

AEFI are notifiable via different routes; immunisation service providers should 

be aware of the method of reporting for their location. In most jurisdictions 

(the Australian Capital Territory, New South Wales, the Northern Territory, 

Queensland, South Australia, Victoria and Western Australia), AEFI should be 

reported directly to the relevant state/territory health authority (see Table 2.3.3). 

AEFI notified to these state and territory health departments are then forwarded 

to the TGA, who manage the ADRS database, which includes all adverse reaction 

reports related to drugs and vaccines. Reporting can also be done directly to the 

TGA as described below. 



Table 2.3.3: Contact information for notification of adverse events 

following immunisation 

State/Territory Report adverse events to Contact information 

Australian Capital 

Territory 

ACT Health Department 02 6205 2300 

New South Wales NSW Public Health Units 1300 066 055 

(for connection to Public 

Health Unit) 

Northern Territory NT Department of Health 08 8922 8044 

Queensland Queensland Health Complete an AEFI initial report 

form, available at: www.health. 

qld.gov.au/immunisation or by 

phoning 07 3328 9888. 

Fax the completed form to the 

number provided on the form. 

South Australia SA Health 1300 232 272 

www.sahealth.sa.gov.au 

Tasmania Direct to the TGA 1800 044 114 

or complete the ‘Blue card’ 

reporting form (see below) 

Victoria SAEFVIC 03 9345 4143 or online at www. 

saefvic.org.au 

Western Australia State Health Department, 

WAVSS 


08 9321 1312 or online at wavss. 

health.wa.gov.au 

Alternatively, reporting directly to the TGA can be done by any person in 

any jurisdiction. Reports are submitted using the ‘Blue card’ adverse reaction 

reporting form. Paper copies of the ‘Blue card’ are available from: 

Office of Product Review 

Therapeutic Goods Administration 

Reply Paid 100 

Woden ACT 2606 

Telephone: 1800 044 114 

or online at www.tga.gov.au/safety/problem-medicines-forms-bluecard.htm. 

Alternatively, the adverse reaction reporting form can be completed and 

submitted online via the TGA website at www.ebs.tga.gov.au/ebs/ADRS/ 

ADRSRepo.nsf?OpenDatabase.

Consumers and immunisation service providers can also report AEFI (and 

adverse drug reactions) via the national Adverse Medicines Events telephone 

reporting line on 1300 134 237. This service is operated by the National 

Prescribing Service (NPS) (www.nps.org.au) and funded by the Australian 

Government through the Department of Health and Ageing. 

The TGA, in turn, forwards copies of individual reports of AEFI from vaccines 

on the NIP schedule back to state/territory health departments for their 

information. 

Information on AEFI reports to the TGA from all sources are aggregated, and 

detailed information on AEFI reporting rates and trends in AEFI are published on 

a 6-monthly basis in the journal Communicable Diseases Intelligence (www.health. 

gov.au/internet/main/publishing.nsf/content/cda-pubs-cdi-cdiintro.htm). 24,51 

2.3.3 Documentation of vaccination 

It is essential that immunisation service providers ensure there is appropriate 

documentation of all vaccinations given to persons of any age. There are a 

number of ways in which this should be done. 

All vaccines administered to children should be documented in the child’s 

clinical file and the individual child health record that is established for all 

newborn infants. This record should be kept by the parent/carer and presented 

every time the child is seen by a health professional. 

Vaccines administered to adolescents and adults should be recorded in both the 

vaccinated person’s clinical file and the personal health record, or individual 

record, of vaccination. The following details should be recorded: 

• the person’s full name and date of birth 

• the details of the vaccine given, including the brand name, batch 

number and dose number 

• the date and time of vaccination 

• the site of administration 

• the name of the person providing the vaccination 

• the date the next vaccination is due. 

Some state/territory health departments also have specific requirements for 

documentation of vaccines administered to healthcare workers/healthcare 

students undertaking work or clinical placement within state/territory health 

facilities. Refer to the relevant state/territory health department for further 

details (see Appendix 1). 

Immunisation service providers should also report vaccination details to the 

appropriate immunisation register(s) – discussed in detail below. 



2.3.4 Immunisation registers 

Australian Childhood Immunisation Register 

The Australian Childhood Immunisation Register (ACIR) is a national database 

for recording details of vaccinations given to children

When relevant, immunisation service providers should complete either the 

‘Medical Contraindication’ or other objection forms and forward these to 

the ACIR. 

For further information about the ACIR and reporting vaccination information, 

see ‘The ACIR on the Internet’ below. In addition, assistance on any reporting 

issues can be obtained from the ACIR Enquiry Line, 1800 653 809 (free call). 

The Australian Childhood Immunisation Register on the Internet 

The Department of Human Services (DHS) website (www.humanservices. 

gov.au/customer/services/medicare/medicare-online-services) houses ACIR 

information and resources. The website has a general information area for 

individuals and families, a general information area for health professionals and 

a secure area for approved immunisation service providers only. 

The secure ACIR Internet site (https://www1.medicareaustralia.gov.au/ssl/ 

acircirssamn) allows approved immunisation service providers to obtain a range 

of statistical and identified reports. Depending on the access level granted to the 

provider, these reports enable approved providers to view a child’s vaccination 

details, record vaccination information and access a range of other reports. 

All health professionals with access to Health Professional Online Services 

(HPOS) can access the ACIR Internet site through this platform. In addition, 

immunisation service providers can register for access to the secure ACIR 

Internet site only by completing the online request form, available from the 

Department of Human Services website. Further information or assistance may 

be obtained by calling the ACIR Internet Helpline on 1300 650 039. 

Immunisation History Statement 

Immunisation History Statements contain details of all vaccines administered 

to a child that are recorded on the ACIR and list the vaccines that are next due. 

These Statements are automatically generated when a child turns 18 months of 

age, 5 years of age, and on completion of the childhood vaccination schedule. 

These Statements will be mailed to the address most recently recorded by 

Medicare for that child. 

Parents/carers can also get an Immunisation History Statement at any other 

time: 

• online at www.humanservices.gov.au/customer/services/medicare/ 

australian-childhood-immunisation-register 

• from their local DHS Service Centres 

• by calling 1800 653 809 (free call). 



Immunisation History Statements can be used to assist in recalling vaccination 

history when required. For example: 

• for school enrolment – a sentence will be displayed at the bottom of the 

Statement that says the child has received all the vaccinations required by 

5 years of age 

• to determine eligibility for the Child Care Benefit and the Family Tax 

Benefit Part A supplement – this requires that children are assessed as 

fully immunised; this replaced the Maternity Immunisation Allowance on 

1 July 2012. 

The ACIR Enquiry Line can be contacted on 1800 653 809 (free call) and any 

record held for a person who is now ≥7 years of age can be made available to an 

immunisation service provider or parent/carer. 

Recording details of a deceased child 

The ACIR should be notified of the death of a child to prevent an Immunisation 

History Statement being sent to bereaved parents/carers. Advice of a child’s 

death can be provided to the ACIR by calling 1800 653 809 (free call), or by 

sending details on practice stationery. Details should include the child’s name, 

address, date of birth, Medicare number and date of death. 

Children who have moved to live overseas 

A child who has moved overseas can be removed from the ACIR by sending 

details to the ACIR by fax, phone or secure site email. This prevents the child’s 

name continuing to appear on ACIR reports of overdue children. 

Children born overseas who have moved to live in Australia permanently 

A child born overseas who has moved permanently to Australia will be 

automatically added to the ACIR upon enrolment with Medicare. Children 

residing temporarily in Australia are not included on the ACIR. 

Ascertaining individual vaccination status 

Parents/carers can telephone the ACIR on 1800 653 809 (free call) for information 

about their child’s vaccination status, regardless of where the child’s vaccination 

was given. Immunisation service providers can also request a child’s vaccination 

status by telephone. 

Vaccination coverage and other reports 

ACIR reports assess progress towards national targets, help to identify areas with 

low vaccination levels, and assist in planning vaccination programs. 

Practices can receive quarterly reports on vaccination coverage for children 

within their practice. Other reports, including those that identify a child’s 

vaccinations and due/overdue details, are available through the secure area 

of the ACIR Internet site (https://www1.medicareaustralia.gov.au/ssl/ 

acircirssamn) to approved immunisation service providers. 


National Human Papillomavirus Vaccination Program Register 

The National HPV Vaccination Program Register (NHVPR), also referred to 

as the ‘HPV Register’, was established following the passing of the National 

Health Amendment Act (National HPV Vaccination Program Register) Bill in 

2007. Establishment and maintenance of the HPV Register facilitates the 

implementation of the National HPV Vaccination Program funded by the 

Australian Government. The HPV Register is run by the Victorian Cytology 

Service, together with the Department of Health and Ageing. It plays an essential 

role in monitoring and evaluating the HPV Vaccination Program by recording 

information about HPV vaccine doses administered in Australia. 

Reporting to the HPV Register 

Details on HPV vaccinations given in the community are provided to the HPV 

Register by the immunisation service provider who administers the vaccine. 

Vaccination details may be submitted electronically, via data uploads or direct 

entry using the secure website, or in hard copy, using one of the approved 

notification forms. Immunisation service providers in Queensland and the 

Northern Territory report data to the HPV Register via their state/territory 

health authority. Immunisation service providers wishing to submit vaccination 

data electronically need to be approved and registered with the HPV Register in 

order to notify administered doses. General practitioners are required to register 

with the HPV Register in order to notify administered doses. Further information 

about registration and notification procedures is available from the HPV Register 

website (www.hpvregister.org.au) or by phoning 1800 478 734 (1800 HPV REG). 

HPV vaccination coverage and other reports 

For immunisation service providers, the HPV Register has developed overdue 

HPV vaccine dose reports for their patients, which are available online via the 

secure website. De-identified HPV vaccination coverage data and other reports 

have also been developed to inform policy making, and support program 

delivery and approved research. National coverage data are made publicly 

available via the Immunise Australia website (www.immunise.health.gov.au). 

HPV Register statements 

The HPV Register sends Completion Statements and History/Reminder 

Statements. Immunisation History Statements, containing details of the 

vaccinations recorded on the HPV Register, are sent to persons who are overdue 

for HPV vaccination within the school-based program. Completion Statements 

are sent to persons who have completed the 3-dose HPV vaccination course. 

Vaccinated persons and parents/guardians can request a statement at any time 

by phoning 1800 478 734 (1800 HPV REG). In the event that booster doses are 

required in future, all eligible persons will be notified by the HPV Register. 



HPV vaccination status 

Vaccinated persons and parents/guardians can phone the HPV Register on 

1800 478 734 (1800 HPV REG) to obtain their or their child’s HPV vaccination 

status. Immunisation service providers can also request a person’s vaccination 

status by phone or can view these online if they are registered with the HPV 

Register. The HPV Register initially only recorded vaccinations for females, but 

from 2013 will also record vaccinations given to males. 

HPV Register secure website 

The HPV Register secure website allows registered and approved immunisation 

service providers access to the live national HPV Register database to view a 

patient’s vaccination history as well as access to overdue dose reports. Further 

information on how to request access to the HPV Register secure website can be 

found on the health professionals page of the HPV Register website 

(www.hpvregister.org.au) or by phoning 1800 478 734 (1800 HPV REG). 

Other immunisation registers 

The Australian Q Fever Register (www.qfever.org), established by Meat and 

Livestock Australia (MLA), has records of receipt of Q fever vaccination for some 

individuals, which can be accessed by registered users (see also 4.15 Q fever). 

State/territory government health departments maintain records of 

immunisations provided through school-based vaccination programs. 

Information on how to access records of vaccines received through school-based 

vaccination programs can be obtained from state/territory government health 

departments (see Appendix 1 Contact details for Australian, state and territory 


Some state/territory governments operate a jurisdictional immunisation register, 

though the scope of these varies. 

Queensland 

The Vaccine Information and Vaccine Administration System (VIVAS) is a 

database of vaccination events for all children up to 10 years of age, adolescents 

and (some) adults in Queensland who are vaccinated with nationally- or statefunded 

vaccines. 

Immunisation service providers in Queensland are encouraged to report all 

vaccinations, either directly to VIVAS via the Queensland Health Vaccination 

Record form or using practice software to electronically transfer data (via the 

ACIR) to Queensland Health. Vaccination Record forms can be posted reply 

paid to VIVAS or faxed directly. Providers reporting to VIVAS should do so at 

least once a week to ensure the supply of data is not delayed and is available 

for the purposes of calculating parental and provider incentive payments using 

ACIR data. 


Immunisation service providers enrolled on VIVAS have access to a range 

of services, such as reminder notices for overdue or unimmunised patients, 

individual vaccination records via local public health units, and Queensland’s 

centralised Vaccine Distribution System (www.health.qld.gov.au/immunisation/ 

health_professionals/vivas.asp). 

The Northern Territory 

The NT Immunisation Register records details of all vaccines administered 

to anyone in the Northern Territory (NT). Immunisation service providers 

in the NT are encouraged to report all administered vaccines to the NT 

Immunisation Register. This can be done by direct electronic transfer from 

some services or via printed lists from clinical software programs and/or by 

completing the NT childhood or adult vaccination recording form 

(www.health.nt.gov.au/Centre_for_Disease_Control/Immunisation/ 

Recording_and_Reporting_Forms/index.aspx). 

The NT Immunisation Register routinely provides relevant data on vaccination 

encounters to the ACIR and the HPV Register. 

The NT Immunisation Register provides a number of services, such as recall lists 

for childhood immunisations in remote areas, individual vaccination records, 

and web-based access for NT immunisation service providers for immunisation 

histories for children

PART 3 VACCINATION FOR SPECIAL RISK GROUPS 

3.1 VACCINATION FOR ABORIGINAL AND 

TORRES STRAIT ISLANDER PEOPLE 

After European colonisation, Aboriginal and Torres Strait Islander (Indigenous) 

peoples experienced successive epidemics of infectious diseases with very 

high morbidity and mortality; many of these diseases have now become 

vaccine preventable. The diseases with the most serious impact were smallpox, 

tuberculosis, influenza, measles and syphilis, with estimated mortality rates of 

over 30% for smallpox epidemics and 20% for measles epidemics. 1 These high 

rates of disease were mainly due to a lack of previous exposure, 2 followed by 

high-density living in newly established settlements. Over many decades, higher 

rates of infectious disease have been associated with lower standards of living 

and poorer access to water, housing and health care. 3 Social determinants of 

health, such as low educational outcomes, lack of control over life circumstances 

and lack of cultural safety, are also associated with poor health outcomes, 

including increased infectious disease risk. 4 

In recent decades, vaccination has been very successful in eliminating or 

substantially reducing the rates of many vaccine-preventable diseases (VPDs), 

such as diphtheria, polio, tetanus, hepatitis B, measles, mumps and rubella, in 

all Australians, and has made a substantial contribution to improvements in 

Indigenous child mortality. 5 For some VPDs, control is suboptimal in the general 

population despite high vaccination coverage (e.g. pertussis). For others, such 

as invasive pneumococcal disease (IPD), greater burdens of illness still occur in 

Indigenous persons than in non-Indigenous persons, largely due to the greater 

prevalence in Indigenous persons of serotypes for which vaccines do not protect, 

and high exposure levels associated with the environmental issues mentioned 

above. 5 Timeliness of immunisation can also be a factor. 5 

In recognition of the higher rates of disease in the Indigenous population, some 

vaccines are specifically recommended for use in Indigenous persons, or for 

administration to a broader age range than is recommended for non-Indigenous 

persons (see Table 3.1.1). This chapter discusses the vaccines for which there are 

currently different recommendations for Indigenous persons in at least some 

parts of Australia, or for which there have been recent changes in this respect. 

For children, these are bacille Calmette-Guérin (BCG), Haemophilus influenzae 

type b, hepatitis A, influenza and pneumococcal vaccines. For adults, these are 

hepatitis B, influenza and pneumococcal polysaccharide vaccines. 



Table 3.1.1: Additional* vaccines recommended for Indigenous persons, due to their higher risk of disease 

Vaccine Recommendation for Indigenous persons 

BCG Neonates living in areas of high TB incidence † 

1 dose 

Hepatitis A Children resident in the Northern Territory, Queensland, South Australia and Western 

Australia 

Hepatitis B 

2 doses in the 2nd year of life‡ 

Adults who have not previously been vaccinated against hepatitis B and are non-immune 

Influenza All persons aged ≥15 years 

Consider in all children aged ≥6 months, especially those aged

3.1.1 Children 

BCG vaccine and tuberculosis 

BCG vaccine is recommended for Indigenous neonates in regions of high 

tuberculosis (TB) incidence, where infants are at higher risk of acquiring this 

serious condition. BCG vaccine is provided for Indigenous neonates in the 

Northern Territory, Queensland and parts of northern South Australia, but 

no longer in Western Australia. 6 State/territory health authorities should be 

consulted to determine the recommendations for particular areas, including 

where BCG vaccination is being considered for neonates

Thus, a vaccine to prevent Hib disease in Indigenous children needed to be 

immunogenic as early as possible in infancy. The previously used Hib-containing 

vaccines, known by the abbreviation PRP-OMP, were more immunogenic at 

2 months of age than the other conjugate Hib (PRP-T) vaccines, and so were the 

preferred Hib vaccine type for Indigenous children in the first Hib vaccination 

programs beginning in 1993. Since then, there has been a dramatic decline in 

Hib disease in Indigenous children. 14,15 New combination vaccines that include 

a Hib (PRP-T) component, and have the advantage of reducing the number of 

injections, were introduced in some jurisdictions from November 2005. Initially 

PRP-T vaccines were not recommended for Indigenous children in jurisdictions 

with higher disease incidence, but either PRP-OMP or PRP-T vaccine could 

be given to other children. Following an international shortage of PRP-OMP 

vaccine, it was progressively replaced by PRP-T-containing vaccines for all 

children. Invasive Hib disease and nasopharyngeal colonisation with Hib are 

being closely monitored in high-incidence settings such as the Northern Territory 

and Western Australia following this change. To date, there has not been any 

change in Hib epidemiology found in association with the change to PRP-Tcontaining 

vaccines for Indigenous children. 

Hepatitis A 

Hepatitis A vaccination is recommended for Indigenous children in those 

jurisdictions with high disease incidence: the Northern Territory, Queensland, 

South Australia and Western Australia (see 4.4 Hepatitis A). Two doses should 

be given, commencing in the 2nd year of life. The recommended ages of 

administration vary between states and territories, so jurisdictional health 

authorities should be contacted for further details about local vaccination 

schedules. 

Hepatitis A infection was common during the 1990s in Indigenous children 

across northern and central Australia. 16-18 Most children acquired the virus in the 

first 5 years of life, which is a typical finding in populations with disadvantaged 

living conditions. Although the symptoms of infection in early childhood 

are usually mild or absent, cases complicated by liver failure and death have 

been reported among Indigenous children in Far North Queensland18 and the 

Kimberley, 16 and recorded hospitalisation rates are more than 50 times higher in 

Indigenous children than in non-Indigenous children. 5 A vaccination program for 

Indigenous children was introduced in north Queensland in 1999 and resulted 

in a 92% decrease in the number of reported cases, from 787 cases in all children 

during the period 1996–1999 to 66 cases in the period 2000–2003. This decrease 

in hepatitis A disease was observed in both Indigenous and non-Indigenous 

children, suggesting a substantial herd immunity effect. 19 From 2005, the 

hepatitis A vaccination program was extended to include all Indigenous children 

aged ≤2 years resident in the Northern Territory, Queensland, South Australia 

and Western Australia. Notifications have fallen by over 90%, from more than 

50 per 100 000 in 2005 to less than 5 per 100 000 in 2009. 


3.1 VACCINATION FOR 

ABORIGINAL AND TORRES 

STRAIT ISLANDER PEOPLE

Hepatitis B 

See ‘Hepatitis B’ under ‘Adults’ below. 

Influenza 

Annual influenza vaccination is recommended for any person ≥6 months of age 

(see 4.7 Influenza) for whom it is desired to reduce the likelihood of becoming 

ill with influenza. Young infants and children aged

3.1.2 Adults 

Hepatitis B 

Indigenous persons should have their risks and vaccination status for 

hepatitis B reviewed, be offered testing for previous hepatitis B infection, and 

be offered vaccination if non-immune. (See also 4.5 Hepatitis B.) 

High rates of mortality and morbidity from hepatitis B among Indigenous 

persons have been recognised ever since the original identification of the 

‘Australia antigen’ in 1965. 29 Prior to vaccination, estimates of the prevalence 

of markers of previous infection in Indigenous communities ranged from 20 

to 100%. In the Northern Territory, the incidence of primary hepatocellular 

carcinoma was 10 times greater in Indigenous persons than in non-Indigenous 

persons, and comparable to high-incidence countries such as China. 30 Vaccination 

programs have had substantial impacts on infection and carriage rates in both 

Indigenous and non-Indigenous Australians. 5,31 However, there is evidence that 

new infections continue to occur at a higher rate in Indigenous persons, 5,32-34 

probably due to a combination of pre-existing high carriage rates, susceptible 

persons in older age groups (who were not eligible for vaccination programs), 33,34 

low coverage in early targeted programs, 33,34 and a poorer immunological 

response to vaccination. 35 

Influenza 

Annual influenza vaccination is recommended for all Indigenous persons aged 

≥15 years (see 4.7 Influenza). 

Influenza and its complications, especially secondary pneumonia, have 

historically been major causes of morbidity and mortality in Indigenous persons, 

both during and outside pandemic periods. This is probably related to a high 

prevalence of medical risk factors such as diabetes, renal disease and excessive 

alcohol use, as well as poorer environmental living conditions that facilitate 

disease transmission. 3 Past pandemics have had disproportionately severe 

impacts on Indigenous persons, 1 as did the influenza A(H1N1)pdm09 pandemic 

in 2009. Reported rates of infection, hospitalisation and death due to pandemic 

A(H1N1)pdm09 were 6.6, 6.2 and 5.2 times higher, respectively, in Indigenous 

persons than in non-Indigenous persons. 36 

In recent times, respiratory disease has been responsible for around 8% of deaths 

in Indigenous persons, the vast majority being in adults. 3 Influenza disease 

incidence is greatest in young children and the elderly. Hospitalisation rates 

due to influenza and pneumonia are highest in young children and lowest in 

older children. Hospitalisation and death rates increase with age in all adults, 

but increase much earlier in Indigenous adults than in non-Indigenous adults. 

The vast majority of these hospitalisations and deaths are due to pneumonia, 

but it is not clear what proportion of these are associated with influenza. 5 

Younger Indigenous adults (aged 25–49 years) have influenza and pneumonia 





disease rates similar to older non-Indigenous adults (aged ≥50 years), but have 

much higher rates than non-Indigenous persons of the same age. In younger 

Indigenous adults rates are at least 8 times higher for hospitalisations and 

20 times higher for deaths, compared to younger non-Indigenous adults. 5 In 

addition, hospitalisation rates in Indigenous children aged

een low in younger Indigenous adults, an issue that requires attention if the 

full benefits of vaccination are to be realised. 5 

Other diseases 


The first ever outbreak of Japanese encephalitis (JE) in Australia occurred in the 

remote outer islands of the Torres Strait in 1995, with 3 cases, 2 of them fatal. 

There have been 5 cases to date acquired in Australia. Since then, JE virus has 

been detected frequently in sentinel animal surveillance in the outer islands. 

However, the sentinel pig surveillance system has been gradually disbanded 

since 2006, with surveillance of the last remaining herd on Cape York ceasing 

from the 2011–2012 wet season. 

A JE vaccine (JE-Vax) was first offered to the residents of the Torres Strait Islands 

in late 1995 and the vaccine was integrated into the vaccination schedule for 

children resident in the Torres Strait Islands, commencing at 12 months of age. 43,44 

There has not been a case of JE in the Torres Strait since 1998 and the risk of 

JE has diminished considerably in the outer islands since the mid-1990s. Most 

communities have relocated pigs well away from homes, and major drainage 

works on most islands have markedly reduced potential breeding sites for 

vector mosquitoes. 

In 2007, the supply of JE-Vax vaccine into Australia ceased as the manufacturer 

stopped production. Because of this shortage of vaccine, for a short period from 

September 2007 JE-Vax was restricted to use on the six outer Torres Strait Islands: 

Badu, Boigu, Dauan, Mabuiag, Moa and Sabai. Two new JE vaccines, Imojev 

and JEspect, are now available for use in those at risk in the Torres Strait 

(see 4.8 Japanese encephalitis). 

Rubella 

Although evidence suggests that endemic rubella is well controlled in Australia, 

Indigenous women living in rural and remote regions are more likely to be nonimmune 

to rubella than non-Indigenous non-overseas-born Australians. 45 Every 

effort should be made to identify non-pregnant seronegative Indigenous women 

of child-bearing age and provide measles-mumps-rubella (MMR) vaccine, in 

order to prevent congenital rubella syndrome (see 4.18 Rubella). Vaccination with 

MMR vaccine also ensures adequate protection against measles (see 4.9 Measles). 





3.1.3 Service delivery 

General practitioners, Aboriginal Community Controlled Health Services, 

Community Health Services, the Royal Flying Doctor Service and state/territory 

corrective services all provide vaccination services to Indigenous persons and 

are important to the success of programs to vaccinate Indigenous persons. While 

vaccination coverage estimates vary over time and between communities, a 

relatively consistent finding has been higher coverage in Indigenous persons in 

remote areas than in urban areas. 46,47 More recently, however, this has not been 

the case for Indigenous children, where coverage has been high in both remote 

and urban areas; 48 coverage in remote areas is lower for adults than for children. 5 

For vaccines recommended for both Indigenous and non-Indigenous persons, 

coverage is as high, or higher, in Indigenous persons as in non-Indigenous 

persons, 5 but vaccination is more frequently delayed. 49-52 For example, one study 

reported that at 7 months of age only 45.2% of Indigenous infants in the Northern 

Territory had completed the recommended schedule for that age point (DTPahepB-IPV-Hib/PCV/rotavirus), 

but by 18 months of age this figure had risen 

to 81.2%. 51 Coverage for vaccines recommended only for Indigenous persons is 

generally lower than for vaccines that are funded for all persons in a particular 

age group. 53 

These disparities point to the importance of identification of Indigenous status, 

particularly in mainstream health services, and particularly in urban areas. The 

use of patient information systems to record Indigenous status and schedule 

preventive health services has the potential to increase opportunistic vaccination 

and enable the provision of patient reminders, with resultant improvements 

in coverage and timeliness. 54 Culturally appropriate service delivery and 

communication strategies, as well as use of Indigenous-specific Medicare 

items, will also assist in improving access to health services for Indigenous 

Australians. 55-57 

References 




3.2 VACCINATION FOR INTERNATIONAL TRAVEL 

3.2.1 Introduction 

The number of Australians who travel overseas has increased over recent years. 

Data available through the Australian Bureau of Statistics suggest that there were 

about 6.7 million short-term departures in 2010, with more than half travelling to 

destinations other than New Zealand or countries in North America and Europe. 1 

There are various risks to health associated with international travel, including 

exposures to infective agents, extremes of altitude and temperature, and other 

physical, psychological and environmental hazards. There could also be poor 

quality or limited access to clean water, shelter, hygiene and sanitation facilities, 

and health and medical care. The level of health risks will vary with individual 

factors, including the travellers’ underlying health and physiological state, the 

itinerary and activities undertaken, and the duration of exposure to various 

hazards during travel. 

Travellers with increased risks to their health include young children and 

infants; pregnant women; people with underlying medical conditions, especially 

immunocompromising conditions due to disease or medical treatment; travellers 

spending extended periods in multiple regions with poor resources or in remote 

regions; those participating in mass gatherings (major sporting, cultural, social 

or religious events involving large numbers of people); and migrant families 

travelling back to their country/region of origin to visit friends and relatives 

(VFR). Those undertaking VFR travel are more likely to have closer contact 

with local populations, stay in remote or rural areas, and consume higher-risk 

food and beverages. They are also less likely to adequately perceive health 

risks associated with travelling, specifically seek pre-travel health advice, or be 

adequately vaccinated or prophylaxed. 2,3 

3.2.2 Infections acquired by travellers 

Exposure to infectious diseases, some of which are vaccine preventable, is one of 

the many health hazards of international travel. Although some of these diseases 

are present in Australia, the risk of acquiring them overseas may be higher 

because of higher disease incidence in other countries and/or increased risk of 

exposure resulting from activities undertaken during the travel period. 

Common infections acquired by travellers include those that follow ingestion 

of contaminated food or beverages. 4,5 Most of these are diarrhoeal diseases due 

to enteric pathogens, but infections with extra-intestinal manifestations, such as 

hepatitis A and typhoid, are also acquired this way. Vaccines against hepatitis A, 

typhoid and cholera are available. 

Insect-borne (particularly mosquito-borne) infections, such as malaria and 

dengue, are important causes of fever in Australian travellers returning from 

endemic areas, particularly Southeast Asia and Oceania. 5 Japanese encephalitis 

occurs throughout a large part of Asia and the Western Pacific region, including 



INTERNATIONAL TRAVEL

Papua New Guinea. Yellow fever occurs only in parts of Africa and Central and 

South America, while tick-borne encephalitis occurs in parts of Europe and Asia. 

Vaccines are available for protection against Japanese encephalitis, yellow fever 

and tick-borne encephalitis. 

Vaccine-preventable infections transmitted via aerosols and/or droplets include 

influenza, meningococcal disease, measles, mumps and varicella (chickenpox); 

influenza is typically the most frequent vaccine-preventable infection among 

travellers. 6 Incidences of measles and mumps are higher in many overseas 

countries, including some developed countries, than in Australia. Tuberculosis is 

a rare infection in travellers, and is more likely to be acquired by expatriates who 

live in endemic areas for long periods than by short-term visitors. 

Blood-borne and sexually transmitted infections, such as hepatitis B, hepatitis C 

and human immunodeficiency virus (HIV), may pose a threat to some Australian 

travellers. In some areas, there is the possibility that these viruses and other 

blood-borne agents may be transmitted by healthcare workers using non-sterile 

medical equipment or other poor infection control practices. Hepatitis B vaccine 

is relevant to many travellers. 

Travellers may be exposed to a variety of other exotic infectious agents, such 

as rabies (from bites or scratches from rabid dogs and other mammals in many 

countries), schistosomiasis (from exposure to water infested with the parasites, in 

Africa in particular), and leptospirosis (through activities like rafting or wading 

in contaminated streams). Of these, only rabies can be prevented by vaccination. 

Some other vector-borne diseases and parasitic (including protozoal and 

helminthic) diseases are also important for international travellers, some 

of which are preventable through appropriate barrier precautions and 

chemoprophylaxis (e.g. malaria). 

3.2.3 Practical aspects of recommending vaccinations for travellers 

Although important, recommending appropriate vaccinations is not the only 

component of a pre-travel medical consultation, and vaccines relevant for 

travelling are not restricted to those for prevention of diseases that occur most 

commonly overseas (‘travel vaccines’). Recommendation of a vaccine for 

travelling only on the basis of the destination country is undesirable. There is no 

single ‘correct’ list of vaccines for travelling to any single country. 

In a pre-travel medical consultation, it is prudent to also acquire adequate 

information regarding: 

• relevant personal information of the traveller, including age, pregnancy 

or planning of pregnancy, or even possible financial constraints 

• underlying medical conditions of the traveller, particularly 

immunocompromising conditions, and current medications 


• vaccination history (including adverse events following immunisation) and 

allergy history of the traveller 

• detailed intended itinerary, including date of departure (and time period 

available for vaccinations), specific localities and routes, rural versus urban 

stay, duration of stay, likely access to healthcare and other services, and 

probability of deviation from planned itinerary 

• purpose(s) of travel and intended activities, especially those susceptible to 

various environmental risks and hazards 

• plans for travel insurance. 

This information will not only facilitate recommendations of preventive 

vaccinations and/or chemoprophylaxis that are commensurate with exposure 

risks and tailored to the proposed trip, but also provision of other important 

preventive health advice (e.g. food and water precautions, avoidance of bites 

from mosquitoes or other arthropods) and advice regarding management of 

possible health conditions during travel. 

Some overseas organisations, such as schools, colleges and universities, have 

policies requiring evidence of vaccination and/or immunity against some 

vaccine-preventable diseases, for example, measles and meningococcal disease. 

These requirements should be taken into account while planning and scheduling 

immunisation prior to departure. 

The vaccination needs for a traveller may be conveniently considered in 

several categories. 

Routinely recommended vaccines (not specifically related to travelling overseas) 

All travellers should be up to date with current standard vaccination 

recommendations. Consideration should also be given to any other vaccines 

that may be relevant to the individual’s health status or underlying medical 

conditions, occupation or lifestyle (e.g. pneumococcal polysaccharide vaccine for 

an elderly person or person otherwise recommended to have had pneumococcal 

vaccine, hepatitis B vaccine for a first aid officer). The probability of exposure 

to some of these diseases may be greater while travelling overseas, even to 

‘developed’ countries (e.g. measles and mumps). For some itineraries, it may be 

appropriate for some booster doses to be received sooner (i.e. before travel) than 

at the routine recommended time (e.g. diphtheria-tetanus booster). 

Selected vaccines based on travel itinerary, activities and likely risk of 

disease exposure 

A risk assessment approach should be adopted in recommending some selective 

vaccines based on travel itineraries (‘travel vaccines’). Potential risks of disease 

exposure and protective benefits from vaccinations should be weighed against 

potential adverse effects and both non-financial and financial costs arising from 

vaccinations. Priority should be given to vaccines for diseases that are common 




and of significant impact (e.g. influenza and hepatitis A), and to those diseases 

that, although less common, have severe potential adverse outcomes (e.g. 

Japanese encephalitis and rabies). Booster doses should be considered where 

appropriate (see Table 3.2.1). Because of the imminence of departure, sometimes 

an ‘accelerated schedule’ may be considered appropriate (e.g. for hepatitis B or 

the combined hepatitis A/hepatitis B vaccine – see the relevant disease-specific 

chapters in Part 4). Note that, while immunity may be established sooner with 

the accelerated schedule, an additional dose is required about a year later for 

completion of the course to augment long-term protection. For children, the 

lower age limits for recommendation of selected vaccines should be noted (see 

Table 3.2.2). 

Vaccines required by International Health Regulations or for entry into 

specific countries 

Currently, yellow fever vaccination is the only vaccination that may be required 

by the International Health Regulations for travelling in certain situations, for 

the purpose of individual protection if one is likely to be exposed and/or for 

protection of vulnerable populations (in countries with relevant vectors) from 

importation of the disease. Some countries, including Australia, may require 

documented evidence of yellow fever vaccination as a condition of entry or exit. 

Although there are exceptions, this would mostly be relevant for travellers who 

originate from, or have travelled or made transit through, countries in Africa or 

South America (see 4.23 Yellow fever and 3.2.6 Further information below). Current 

requirements should be referred to when advising travellers regarding yellow fever 

immunisation requirements. 

The Ministry of Health of Saudi Arabia annually issues specific requirements 

and recommendations for entry visas for travellers on pilgrimage to Mecca in 

Saudi Arabia (Hajj and Umra). For pilgrims travelling directly from Australia, 

only evidence of quadrivalent meningococcal vaccination is currently mandatory. 

However, current requirements should be referred to when advising prospective 

Hajj and Umra pilgrims (see 3.2.6 Further information below). 

Vaccine administration and documentation 

It is not unusual that multiple vaccines would be required before travelling. 

The standard recommendations and precautions for administration of multiple 

vaccines are applicable (see 2.2 Administration of vaccines). 

Multiple clinic visits may be necessary when multiple vaccines and vaccines 

that involve multiple doses are involved (e.g. rabies pre-exposure prophylaxis 

or hepatitis B vaccine). Special attention should be paid to the appropriate 

scheduling of these visits, taking into account dose interval precautions (e.g. 

multiple live vaccines), requirement for pre-vaccination tests (e.g. tuberculin 

skin test), and potential interference by some antimalarials if relevant (e.g. rabies 

vaccine). Ideally, vaccination courses should be started early enough before 


departure to allow for the period when most adverse events are expected to 

occur and to allow sufficient time for adequate immunity to develop. 

It is important to document travel vaccines appropriately, not only in the 

clinic’s record but also in a suitable record that can be carried by the traveller. 

It is recommended that the record also includes all the other ‘routinely 

recommended’ vaccines that the traveller has ever received. An International 

Certificate of Vaccination or Prophylaxis (ICVP), issued by an authorised medical 

practitioner in accordance with the International Health Regulations (2005), is 

required for yellow fever vaccination. 

3.2.4 Vaccines 

Detailed information regarding each of the vaccines discussed below is provided 

in each of the corresponding disease-specific chapters of this Handbook. This 

section provides some general guidance in considering whether a particular 

vaccine may be advisable for a traveller. 

All prospective travellers should have been vaccinated according to the 

recommended vaccination schedule appropriate for the traveller’s age and 

underlying health conditions. All children should be vaccinated according 

to the NIP schedule. In exceptional circumstances, the NIP vaccines may be 

administered at the minimum age rather than the recommended age (see 2.1.5 

Catch-up, Table 2.1.5 Minimum acceptable age for the 1st dose of scheduled vaccines 

in infants in special circumstances). Children vaccinated using the minimum age 

rather than the recommended age may require extra vaccine doses to ensure 

adequate protection. The minimum interval requirements between doses must 

be observed (see 2.1.5 Catch-up, Table 2.1.7 Minimum acceptable dose intervals for 

children

of intermediate or high endemicity of hepatitis B, including Central and South 

America, Africa, Asia or Oceania, are recommended to be vaccinated against 

hepatitis B, due to the potential for inadvertent exposure to hepatitis B virus 

through blood-borne or sexual routes, including unplanned medical or dental 

procedures. A survey has shown that about half of Australian travellers who 

spent at least 3 nights in Southeast or East Asia had participated in at least one 

activity with a risk of acquiring hepatitis B. 7 (See also 4.5 Hepatitis B.) 

Influenza and pneumococcal disease 

Older travellers (usually those aged ≥65 years) and those with any relevant 

underlying medical or behavioural risk factors (see 4.7 Influenza and 4.13 

Pneumococcal disease) should receive the seasonal influenza vaccine and/or 

should have received the 23-valent pneumococcal polysaccharide vaccine. All 

travellers should consider influenza vaccine, especially if travelling during the 

influenza season of the destination region(s). The influenza vaccine is particularly 

relevant if influenza epidemics are occurring at the traveller’s destination(s), and 

for travellers in large tourist groups, especially those that include older persons, 

or travelling on cruises, where they are likely to be in confined circumstances for 

days to weeks (see 4.7 Influenza). 

Measles, mumps, rubella and varicella 

Most measles outbreaks in Australia now result from an infection imported by 

inadequately vaccinated young travellers. Incidences of measles and mumps are 

higher in some overseas countries, regions or communities, including developed 

countries, than in Australia. Australians born during or since 1966 who have 

not received 2 doses of measles-, mumps- and rubella-containing vaccines 

should be vaccinated with the MMR vaccine before travelling (noting pregnancy 

precautions) (see 4.9 Measles). Varicella vaccine should be offered to unvaccinated 

travellers who have not had clinical disease, or where serology demonstrates 

lack of immunity in those with an uncertain history of clinical disease (see 4.22 

Varicella). 

Poliomyelitis 

All travellers should be age-appropriately immunised against polio (see 4.14 

Poliomyelitis). If travelling to countries where wild poliovirus transmission still 

occurs (i.e. Afghanistan, Pakistan, Nigeria and others where polio may have 

been re-established or have been imported – check recent updates), inactivated 

poliomyelitis vaccine (IPV) should be offered to those who have not completed a 

3-dose primary course of any polio vaccine, and a single booster dose should be 

given to those who have previously completed the primary course. For an up-todate 

list of affected countries see www.polioeradication.org. 


Selected vaccines based on travel itinerary, activities and likely risk of 

disease exposure 

Cholera 

Cholera vaccination is rarely indicated for most travellers, 8 as the risk of 

acquiring cholera for travellers in general is very low, provided that general 

precautions to avoid contaminated food and water are taken. The protective 

efficacy against Vibrio cholerae O1 is high (>80%) among children aged 2–5 

years for the initial 4–6 months after 3 doses, but wanes to become insignificant 

afterwards. For those aged >5 years, protective efficacy is about 78% and 63% for 

the 1st and 2nd year, respectively, and wanes to become insignificant beyond 2 

years after vaccination. 9 The vaccine does not protect against the V. cholerae O139 

serogroup. It is only indicated for those travellers at considerable risk, such as 

those working in humanitarian disaster situations. However, since cholera and 

enterotoxigenic Escherichia coli (ETEC) share the same toxin, cholera vaccination 

does afford some partial short-term protection against ETEC-caused travellers’ 

diarrhoea. The effect lasts only about 3 months, and the overall reduction of 

travellers’ diarrhoea risk would be less than 15%; 10 however, there may be some 

travellers who would benefit from improved protection against travellers’ 

diarrhoea, including those with achlorhydria and those at increased risk of severe 

or complicated diarrhoeal disease (see 4.1 Cholera). 

Certification of cholera vaccination has been abandoned globally, and no 

countries have official entry requirements for cholera vaccination. 

Hepatitis A 

Hepatitis A vaccine should be recommended to all travellers ≥1 year of age 

travelling to moderately or highly endemic countries (including all developing 

countries), except those who are likely to have acquired natural immunity 

following previous infection (see 4.4 Hepatitis A). There is no longer any place 

for the routine use of normal human immunoglobulin to prevent hepatitis A in 

travellers (see 4.4 Hepatitis A). 


The mosquito-borne Japanese encephalitis virus is endemic in many countries 

in Asia and the Western Pacific region, including Papua New Guinea. High risk 

of transmission occurs in rural irrigated paddy and pig-farming environments. 

Vaccination is recommended for travellers spending a month or more in rural 

areas of high risk in endemic regions and should be considered for shorter-term 

travellers, particularly if travel is during the wet season or anticipated to be 

repeated, and/or there is considerable outdoor activity and/or accommodation 

is inadequately screened against mosquitoes. Vaccination is also recommended 

for expatriates spending a year or more in Asia, even if much of the stay is in 

urban areas (see 4.8 Japanese encephalitis). 




Meningococcal disease 

All children ≥12 months of age receive meningococcal C conjugate vaccine 

(MenCCV) under the NIP. 

Up-to-date epidemiological information should be sought to determine the need 

for meningococcal vaccination in travellers. The quadrivalent meningococcal 

vaccine (which includes serogroups A, C, W and Y antigens) is recommended 

135 

for those who intend travelling to parts of the world where epidemics of 

meningococcal disease occur, in particular the ‘meningitis belt’ of sub-Saharan 

Africa. 11 The Saudi Arabian authorities require that all pilgrims travelling to 

Mecca (for the Hajj or Umra) have evidence of recent vaccination with the 

quadrivalent meningococcal vaccine8 (see 3.2.6 Further information below). The 

quadrivalent meningococcal conjugate vaccine (4vMenCV) should be used in 

preference to the quadrivalent meningococcal polysaccharide vaccine (4vMenPV) 

(see 4.10 Meningococcal disease). There is currently no vaccine available against 

serogroup B meningococcal disease. 

Rabies 

Travellers to rabies-endemic regions should be advised of the risk of rabies 

infection, and to avoid close contact with either wild, stray or domestic animals, 

in particular dogs, cats, monkeys and bats. Travellers should also be aware of 

the importance of appropriate immediate wound care of all animal bites and 

scratches (see 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus)). 

Recommendation for pre-travel (i.e. pre-exposure prophylaxis) rabies vaccination 

(or, where indicated, booster doses) is based on an assessment of the likelihood 

of contact and risk of exposure to potentially rabid animals, the access to 

appropriate healthcare and availability of post-exposure prophylaxis, including 

rabies immunoglobulin, should there be an at-risk exposure, and the timeliness 

of such access after exposure. The previous recommendation for pre-exposure 

prophylaxis based on duration of stay in rabies-endemic areas (i.e. for more 

than a month) is arbitrary, and most Australian travellers who have required 

post-exposure prophylaxis have undertaken shorter periods of travel. A lower 

threshold for recommending rabies pre-exposure prophylaxis should be adopted 

for children travelling to endemic areas (see 4.16 Rabies and other lyssaviruses 

(including Australian bat lyssavirus)). Vaccination against rabies before travel 

ensures that a safe and efficacious vaccine has been used and simplifies the 

management of a subsequent exposure because fewer doses of vaccine are 

needed. It also means that rabies immunoglobulin, which is often extremely 

expensive, difficult or even impossible to obtain in many developing countries, is 

not required, and reduces the urgency of post-exposure prophylaxis. 


Tick-borne encephalitis 

Tick-borne encephalitis (TBE) is caused by a tick-borne RNA flavivirus and 

may involve the central nervous system. The disease is prevalent in parts of 

temperate regions of central and northern Europe and across northern Asia. 

Travellers are at particular risk when hiking or camping in forested areas in 

endemic regions during the summer months. Safe and effective vaccines are 

available. Vaccination is recommended only for individuals with a high risk 

of exposure. Two inactivated TBE vaccine formulations (from Austria and 

Germany) are available in Europe (based on the European subtype), and two 

other formulations, based on the Far Eastern subtypes, are available in Russia. 

There is limited evidence that suggests the Austrian and German vaccines induce 

cross-protecting immunity against the Far Eastern and Siberian subtypes. 12 While 

the conventional schedule for completing the primary vaccination course takes 

9 to 12 months, accelerated schedules are available (see 3.2.6 Further information 

below). While no TBE vaccine is registered in Australia, a small stock of vaccine 

may be available in Australia for use under the Special Access Scheme. 

Tuberculosis 

Vaccination with BCG vaccine is generally recommended for tuberculinnegative 

children

Typhoid 

Typhoid vaccine may be recommended to travellers ≥2 years of age travelling 

to endemic regions, including the Indian subcontinent, most Southeast Asian 

countries and several South Pacific nations, including Papua New Guinea. This 

advice is also relevant for those travelling (back) to endemic regions to visit 

friends and relatives (VFR travel). Inactivated parenteral or live oral typhoid 

vaccine formulations are available (see 4.21 Typhoid). 

Yellow fever 

The World Health Organization no longer routinely reports on yellow fever 

‘infected areas’. The yellow fever vaccine is now recommended for all travellers 

aged ≥9 months to areas where there is evidence of persistent or periodic 

yellow fever virus transmission, or when required by the country for entry (see 

4.23 Yellow fever). 3 Countries requiring yellow fever vaccination for entry have 

legislation to do so in accordance with the International Health Regulations. 

Country requirements are subject to change at any time. Updates can be 

found at www.who.int/ith. To minimise the risk of yellow fever introduction, 

some countries, including those without current disease transmission such as 

Australia, may require proof of vaccination from travellers who have travelled 

to countries with risk of transmission. See also the Australian Government 

Department of Health and Ageing’s yellow fever fact sheet (www.health.gov.au/ 

yellowfever). 

The risk of being infected with the yellow fever virus, country entry 

requirements, and individual factors like age, pregnancy and underlying 

medical conditions must be taken into account when considering yellow fever 

vaccination. Vaccination is generally not recommended when travelling to areas 

where there is low potential for yellow fever virus exposure (i.e. no human 

yellow fever cases ever reported and evidence to suggest only low levels of 

yellow fever virus transmission in the past). However, vaccination might be 

considered for a small subset of travellers to these areas who are at increased 

risk of exposure to mosquitoes or unable to avoid mosquito bites. 3 For people 

aged ≥60 years, the risk of adverse events associated with the vaccine should be 

weighed against the potential for disease exposure and benefit of yellow fever 

vaccination, as this age group has an increased risk of severe adverse events after 

primary yellow fever vaccination13 (see 4.23 Yellow fever). 



Table 3.2.1: Dose and routes of administration of commonly used vaccines in adult travellers (the lower age limit for the 

adult dosage varies with individual vaccines – please refer to the product information) 

Vaccine (adults) Brand name Dose (adults) Route Dosing intervals Duration of immunity and/or 

booster recommendations 


Diphtheria-tetanus 

(dT) 

Diphtheria-tetanuspertussis 

(dTpa) 

Diphtheria-tetanuspertussis-inactivated 

poliomyelitis (dTpa- 

IPV) 

ADT Booster 0.5 mL IM A primary course is 3 doses 

of dT-containing vaccine, 

Boostrix 

0.5 mL IM 

given a minimum of 4 weeks 

apart; followed by booster 

or 

Adacel 

doses 10 and 20 years after. 

Boostrix-IPV 

or 

Adacel Polio 

0.5 mL IM 

Hepatitis B Engerix-B 1.0 mL IM 0, 1, 6 months or 

0, 1, 2, 12 months or 

0, 7, 21 days and 12 months* 

H-B-Vax II 1.0 mL IM 0, 1, 6 months 

Influenza (seasonal) Various 0.5 mL IM or 

intradermal, 

depending on the 

formulation 


INTERNATIONAL TRAVEL 

Prior to travel, adults should receive 

a booster dose of dT (or dTpa if not 

given previously), if more than 10 

years have elapsed since their last 

dose of dT-containing vaccine. 

For persons undertaking high-risk 

travel, consider giving a booster 

dose of either dTpa or dT (as 

appropriate) if more than 5 years 

have elapsed since their last dose of 

dT-containing vaccine. 

A completed series probably gives 

life-long immunity. 

Single dose As different strains circulate from 

year to year, annual vaccination 

with the current formulation is 

necessary.





Measles-mumpsrubella 

Pneumococcal Prevenar 13 

or 

Pneumovax 23 

Priorix 0.5 mL SC/IM Australians born during 

or since 1966 who do not 

have documented evidence 

of having received 2 doses 

of measles-, mumps- and 

M-M-R II 0.5 mL SC 

rubella-containing vaccine 

should receive at least 1 

dose of MMR vaccine before 

travel 

0.5 mL IM Single dose, for older 

adults, and younger adults 

with predisposing medical 

conditions – see 4.13 

Pneumococcal disease 

Poliomyelitis IPOL 0.5 mL SC For unvaccinated adults, 

3 doses with minimum 

interval of 1 to 2 months 

between doses 

Combination 

vaccines (dTpa- 

IPV) 

Varicella (chickenpox) Varilrix 

or 

Varivax 

Refrigerated 

A 2-dose schedule provides longlasting 

immunity. 

Recommendations vary according 

to age, Indigenous status and 

predisposing conditions – see 4.13 

Pneumococcal disease. 

A booster dose 10-yearly is 

only necessary if travelling to a 

poliomyelitis endemic country. 

See Diphtheria-tetanus-pertussis-inactivated poliomyelitis (dTpa-IPV) above and 4.14 Poliomyelitis. 

0.5 mL SC If there is a lack of reliable 

history of chickenpox or the 

person is non-immune, and 

has not been vaccinated in 

childhood 

0, 4 weeks if aged ≥14 years 

A 2-dose schedule provides longlasting 

immunity.




Selected vaccines based on travel itinerary, activities and likely risk of disease exposure 

Hepatitis A Avaxim 0.5 mL IM 0, 6–12 months A completed series probably gives 

Havrix 1440 1.0 mL IM 0, 6–12 months 

life-long immunity. 

Hepatitis A/B 

combined 

Hepatitis A/typhoid 

combined 

Vaqta Adult 

formulation 

1.0 mL IM 0, 6–18 months 

Twinrix (720/20) 1.0 mL IM 0, 1, 6 months or 

0, 7, 21 days and 12 months* 

Vivaxim † 

Note: Only for use 

in persons ≥16 

years of age 

1.0 mL (mixed 

vaccine) 


INTERNATIONAL TRAVEL 

A completed series probably gives 

life-long immunity to both hepatitis 

A and B. 

IM Single dose A dose of monovalent hepatitis A 

vaccine given 6–36 months later 

probably gives life-long immunity. 

The duration of protection against 

typhoid is probably 3 years. 

Japanese encephalitis JEspect 0.5 mL IM 0, 28 days The need for, and timing of, a 

booster dose has not yet been 

determined. 

Meningococcal 

ACW 135 Y 

(quadrivalent 

conjugate 4vMenCV) 

Imojev 0.5 mL SC Single dose The need for, and timing of, a 


determined. 

Menveo 

or 

Menactra 

0.5 mL IM Single dose The need for, and timing of, a 


determined. Where not otherwise 

indicated 4vMenCV should be 

given in preference to 4vMenPV.




Selected vaccines based on travel itinerary, activities and likely risk of disease exposure 

Meningococcal 

ACW 135 Y 

(quadrivalent 

polysaccharide 

4vMenPV) 

Rabies (pre-exposure 

prophylaxis) 

Mencevax ACWY 

or 

Menomune 

Mérieux 

Inactivated 

Rabies Vaccine 

Rabipur 

Inactivated 

Rabies Virus 

Vaccine 

Typhoid Vivotif Oral A single oral 

capsule per 

dose 

Typherix 

or 

Typhim Vi 

0.5 mL SC Single dose Where not otherwise indicated, 

4vMenCV should be given in 

preference to 4vMenPV. 

Give 3–5-yearly boosters if the 

person is at ongoing risk. 

1.0 mL IM/SC 0, 7, 21–28 days Boosters are not recommended for 

frequent travellers unless they are 

at ongoing, high occupational risk 

1.0 mL IM 0, 7, 21–28 days 

of exposure – then either measure 

rabies antibody titres (and boost if 

titres are reported as inadequate) or 

give a single booster dose 2-yearly. 

Oral One capsule each on days 

1, 3, 5 (3-dose course), and 

preferably also day 7 ‡ (4-dose 

course) 

If the person is at ongoing risk, 

repeat the course after 3 years if a 

3-dose course was given initially; 

repeat the course after 5 years if a 

4-dose course was given initially. 

0.5 mL IM Single dose Give 3-yearly boosters if the person 

is at ongoing risk. 

Yellow fever Stamaril 0.5 mL IM/SC Single dose Give 10-yearly boosters if the 

person is at ongoing risk. 

* This ‘rapid’ schedule should be used only if there is very limited time before departure to endemic regions. 

† Vivaxim is registered for use in persons aged ≥16 years. 

‡ A 4th capsule of oral typhoid vaccine on day 7 is preferred (see 4.21 Typhoid).

3.2.5 Vaccinating the traveller with special risk factors 

See 3.3 Groups with special vaccination requirements and the disease-specific 

chapters in Part 4 for recommendations for travellers who are either pregnant or 


Children should receive relevant travel vaccines, according to age-specific 

dosage and schedules as shown in Table 3.2.2; further information relating to 

administration is provided in the relevant disease-specific chapters in Part 4. 

Particular effort should be made to encourage the families of recent migrants to 

Australia to seek health advice before travelling to their country of origin to visit 

relatives and friends. 14 

Table 3.2.2: Recommended lower age limits of travel vaccines for children* 

Vaccine Lower age limit Dose/route Dosing intervals 

Hepatitis A 

Avaxim 

Havrix Junior 

Vaqta Paediatric/Adolescent 

formulation 

Hepatitis A/B combined 

Twinrix Junior (360/10) 

Twinrix (720/20) 


JEspect 

Imojev 

Meningococcal ACW 135 Y 

(quadrivalent conjugate 

4vMenCV) 

Menveo 

2 years 

2 years 

1 year 

1 year 

1 year 

1 year (to

Vaccine Lower age limit Dose/route Dosing intervals 

Rabies 

Pre-exposure: 

Mérieux Inactivated Rabies 

Vaccine 

Rabipur Inactivated Rabies 

Virus Vaccine 

Typhoid 

Vivotif Oral 

Typherix 

Typhim Vi 

Yellow fever 

No lower age limit 

No lower age limit 

6 years 

2 years 

2 years 

1.0 mL IM/ 

SC 

1.0 mL IM 

Oral capsule 

0.5 mL IM 

0.5 mL IM 

Stamaril 9 months # 0.5 mL IM/ 

SC 


3 doses: 0, 7, 21–28 days 

3 doses: 0, 7, 21–28 days 

One capsule each on days 

1, 3, 5 (3-dose course), and 

preferably also day 7 (4-dose 

course) 

Single dose 

Single dose 

Single dose 

* See also minimum ages in Table 2.1.5 Minimum acceptable age for the 1st dose of scheduled vaccines in 

infants in special circumstances. 

† This schedule is not recommended if prompt protection against hepatitis B is required 

(see 4.5 Hepatitis B). 

‡ JEspect is registered for use in persons aged ≥18 years, but can be administered to persons 

aged ≥12 months in circumstances where an alternative is not available or contraindicated 

(see 4.8 Japanese encephalitis). 

§ 4vMenCV is preferred over 4vMenPV (see 4.10 Meningococcal disease). 

A 4th capsule of oral typhoid vaccine on day 7 is preferred (see 4.21 Typhoid). 

# Yellow fever vaccine is contraindicated in infants

• Travel health and quarantine section of the Australian Government Department 

of Health and Ageing website (www.health.gov.au/internet/main/ 

publishing.nsf/Content/health-pubhlth-strateg-quaranti-index.htm) 

• Smartraveller – the Australian Government’s travel advisory and consular 

information service, which provides up-to-date advice regarding health, 

safety and other risks of specific destinations to Australian travellers (www. 

smartraveller.gov.au). 

Comprehensive technical advice on international travel and health, including 

but not limited to vaccinations, is available in the latest editions of the WHO 

publication International travel and health (available at www.who.int/ith/en) and 

the US Centers for Disease Control and Prevention (CDC) publication Health 

information for international travel (the ‘Yellow book’) (available at www.cdc.gov/ 

travel). 

The Ministry of Health of Saudi Arabia’s requirements and recommendations for 

travellers on pilgrimage to Mecca (Hajj and Umra) are published annually in the 

Weekly Epidemiological Record of the WHO (www.who.int/wer). 8 

References 






3.3 GROUPS WITH SPECIAL VACCINATION REQUIREMENTS 

This chapter considers the use of vaccines in persons who have special 

vaccination requirements, persons who may experience more frequent 

adverse events following immunisation and persons who may have a 

suboptimal response to vaccination. Recommendations for vaccination of 

persons at occupational or lifestyle-associated risk are also included. Although 

recommendations are discussed under each sub-heading in this chapter, it is 

also important to refer to the relevant disease-specific chapters in Part 4 for 

further information. 

Administration of certain vaccines is a priority for some persons with 

medical conditions that increase the risk of infectious diseases, even in the 

absence of specific immune defects, for example, the use of influenza and 

pneumococcal vaccines in individuals with an increased risk of complications 

from these diseases. The presence of additional recommendations specific to 

groups discussed in this section underpins the importance of pre-screening 

those attending for immunisation and being certain to regularly review the 

vaccination needs of those seeking medical attention for any reason. 

3.3.1 Vaccination of persons who have had an adverse event 

following immunisation 

Adverse reactions after being given a vaccine (also known as ‘vaccine side 

effects’) do sometimes occur. It is usually not possible to predict which 

individuals may have a mild or a rare, serious reaction to a vaccine. However, by 

following guidelines regarding when vaccines should and should not be used, 

the risk of adverse effects can be minimised. The term ‘adverse event following 

immunisation’ (AEFI) refers to any untoward medical occurrence that follows 

immunisation, whether expected or unexpected, and whether triggered by the 

vaccine or only coincidentally occurring after receipt of a vaccine dose. 1 For more 

information on AEFI, see 2.3.2 Adverse events following immunisation. 

Serious adverse events occur rarely after immunisation. Recognised rare 

and serious AEFI are described in 2.3.2 Adverse events following immunisation. 

Pre-vaccination screening should identify persons who have experienced an 

AEFI and also identify persons with conditions that are precautions and/or 

contraindications to vaccines (see Table 2.1.1 Pre-vaccination screening checklist). 

The relevant disease-specific chapter(s) in Part 4 of this Handbook should be 

consulted for each vaccine regarding contraindications and precautions that are 

relevant. In general, persons who have had a non-serious adverse event can be 

safely revaccinated by their usual immunisation service provider. Determining 

whether revaccination should be provided after a serious event has occurred 

following vaccination can be more challenging. At the individual patient 

level, an assessment should be made as to whether the vaccine(s) was causally 

related to the adverse event. This includes a thorough medical assessment, 

including determining the need for, or availability of, specific tests to predict 


whether the AEFI is likely to recur with subsequent doses. Persons who have 

experienced a serious adverse event following immunisation (other than a 

contraindication, such as anaphylaxis confirmed as triggered by a vaccine or one 

of its components) can usually subsequently be vaccinated under close medical 

supervision. However, further advice should be sought where appropriate, 

by referral to a specialist clinic for the management of persons with special 

vaccination requirements (including persons who have had a previous AEFI). 

Information about specialist immunisation clinics, or the contact details for 

paediatricians or medical specialists with experience in management of persons 

with AEFI, are usually available from state and territory health authorities (see 


authorities and communicable disease control) and from the Immunise Australia 

website (www.immunise.health.gov.au). 

Allergies 

Vaccines rarely produce allergy or anaphylaxis (a rapid and life-threatening 

form of allergic reaction). Overall, the risk of anaphylaxis after a single vaccine 

dose has been estimated as less than 1 case per 1 million; however, this risk 

varies depending on the vaccine type. 2 Antibiotics, gelatin and egg proteins 

are the components most often implicated in allergic reactions. Yeast has only 

rarely been associated with vaccine-related allergic reaction. Persons allergic to 

latex may be at risk from some vaccines. This is usually not from the vaccine 

formulation itself, but from the presence of latex in the equipment used to 

hold the vaccine, such as vaccine vial stoppers (bungs) and syringe plungers. 

However, very few vaccine bungs contain natural latex. Before administering 

the vaccine, consult the product information (PI) of each vaccine to check for the 

presence of latex or, where not listed on the PI, contact the vaccine manufacturer 

for specific details. 

It is important that immunisation service providers assess each individual 

for a history of allergies and previous reactions to vaccines prior to giving 

any dose of vaccine. Depending on the allergy identified, there often may 

not be a contraindication to vaccination. For example, a history of allergy to 

antibiotics most commonly relates to β-lactam or related antibiotics and is not a 

contraindication to vaccines that contain neomycin, polymyxin B or gentamicin. 

Previous reactions to neomycin that only involved the skin are not considered a 

risk factor for a severe allergic reaction or anaphylaxis to vaccines manufactured 

with neomycin because there are only trace amounts of this antibiotic in the final 

product. 3 Similarly, the measles and mumps components of measles-mumpsrubella 

(MMR) vaccine contain only a negligible quantity of egg ovalbumin 

and do not contraindicate MMR vaccination of persons with egg allergy (even 

anaphylaxis) (see ‘Vaccination of persons with a known egg allergy’ below). 4-7 

It is important that persons who experience an allergic reaction associated with a 

vaccine dose are fully investigated appropriately to ascertain the possible causal 


3.3 GROUPS WITH SPECIAL 

VACCINATION REQUIREMENTS

elationship to vaccination, and determine if, and under what circumstances, 

repeat doses of vaccine can be provided. Specialist advice should be sought 

where appropriate (see above). 

Vaccination of persons with a known egg allergy 

Influenza vaccines 

A history of anaphylaxis or a severe allergic reaction to eggs has previously been 

considered an absolute contraindication to influenza vaccination. However, 

there have now been a number of studies indicating that the majority of persons 

with egg allergy, including anaphylaxis, can be safely vaccinated with influenza 

vaccines that contain less than 1 μg of ovalbumin per dose8-10 (see 4.7 Influenza). 

The majority of vaccine-associated anaphylaxis cases reported as likely due to 

egg allergy occurred following administration of one of the older formulations 

of influenza vaccine. 9 Today, due to manufacturing changes, the quantity of 

egg ovalbumin present in the majority of influenza vaccines used in Australia 

is less than 1 μg of ovalbumin per dose. 8 Note that the amount of residual egg 

ovalbumin may vary from year to year due to manufacturing processes, vaccine 

batches and country of origin. The PI of the vaccine to be given should be 

checked for the vaccine’s ovalbumin content prior to vaccine administration. 8,9,11,12 

Given that there is still a small risk of anaphylaxis, it is essential that persons 

with a history of a severe allergic reaction to eggs are vaccinated in facilities that 

have staff who are able to recognise and treat anaphylaxis. 8,9 Allergy testing (e.g. 

skin testing) with influenza vaccine prior to administration is not recommended, 

as there is poor correlation between test results and vaccine tolerance. 8,9 Detailed 

information on influenza vaccination of individuals with an allergy to eggs 

can be found in the Australasian Society of Clinical Immunology and Allergy 

(ASCIA) guidelines8 (available at www.allergy.org.au/health-professionals/ 

papers/influenza-vaccination-of-the-egg-allergic-individual). 

Other vaccines 

Vaccines used in Australia that contain traces of egg ovalbumin, in addition to 

most influenza vaccines, are: 

• rabies vaccine, Rabipur (see 4.16 Rabies and other lyssaviruses (including 

Australian bat lyssavirus)) 

• yellow fever vaccine, Stamaril (see 4.23 Yellow fever) 

• Q fever vaccine, Q-Vax (see 4.15 Q fever). 

Of these vaccines, yellow fever and Q fever vaccines contain a higher amount of 

ovalbumin than is present in the currently available influenza vaccines and are 

contraindicated in persons with known severe allergy to eggs. Persons with egg 

allergy requiring vaccination with either yellow fever or Q fever vaccines should 

seek specialist immunisation advice from state or territory health authorities 


(see Appendix 1 Contact details for Australian, state and territory government health 

authorities and communicable disease control). 

For rabies vaccination, pre- or post-exposure vaccination should be undertaken 

using the human diploid cell vaccine (HDCV; Mérieux Inactivated Rabies 

Vaccine), and not using the purified chick embryo cell vaccine (PCECV; Rabipur 

Inactivated Rabies Virus Vaccine) (see 4.16 Rabies and other lyssaviruses (including 

Australian bat lyssavirus)). 

Although measles and mumps (but not rubella or varicella) vaccine viruses are 

grown in chick embryo tissue cultures, it is now recognised that measles- and 

mumps-containing vaccines contain negligible amounts of egg ovalbumin 

and can be safely administered to persons with a known egg allergy (see 4.9 

Measles). 4-7 

3.3.2 Vaccination of women who are planning pregnancy, 

pregnant or breastfeeding, and preterm infants 

Women planning pregnancy 

The need for vaccination, particularly for hepatitis B, measles, mumps, rubella, 

varicella, diphtheria, tetanus and pertussis, should be assessed as part of any 

pre-conception health check. Where previous vaccination history or infection is 

uncertain, relevant serological testing can be undertaken to ascertain immunity to 

hepatitis B, measles, mumps and rubella. Routine serological testing for pertussis 

and varicella does not provide a reliable measure of vaccine-induced immunity, 

although varicella serology can indicate whether previous natural infection has 

occurred (see 4.22 Varicella). Influenza vaccine is recommended for any person 

who wishes to be protected against influenza and is recommended for women 

planning pregnancy. Those with risk factors for pneumococcal disease, including 

smokers and Aboriginal and Torres Strait Islander women, should be assessed 

for pneumococcal vaccination. Women who receive live attenuated viral vaccines 

should be advised against falling pregnant within 28 days of vaccination. 

Refer to the relevant disease-specific chapters in Part 4 for more information 

about vaccination requirements for these diseases. 

It is also important that women of child-bearing age who present for 

immunisation should be questioned regarding the possibility of pregnancy as 

part of the routine pre-vaccination screening, to avoid inadvertent administration 

of a vaccine(s) not recommended in pregnancy (see 2.1.4 Pre-vaccination 

screening). 

Pregnant women 

Table 3.3.1 summarises the recommendations for vaccine use in pregnancy. More 

detailed information is also provided under the ‘Pregnancy and breastfeeding’ 

sections of each disease-specific chapter in Part 4 of this Handbook. 




Seasonal influenza vaccine is the only vaccine routinely recommended for 

pregnant women. dTpa vaccine can also be given in pregnancy, as an alternative 

to providing it immediately post-partum. Vaccination with dTpa during 

pregnancy will provide timely protection against pertussis in both the mother 

and her newborn child. 

Many other inactivated vaccines are not routinely recommended during 

pregnancy on precautionary grounds; however, there is no convincing evidence 

that pregnancy should be an absolute contraindication to vaccination with 

these vaccines. There is some evidence that fever per se is teratogenic; however, 

in clinical studies most inactivated vaccines are not associated with increased 

rates of fever in adults (as compared with placebo). 13,14 Recommendations 

regarding vaccine use in pregnancy are made where the benefits of protection 

from vaccination outweigh the risks. Eliminating the risk of exposure to vaccinepreventable 

diseases during pregnancy (e.g. by changing travel plans, avoiding 

high-risk behaviours or occupational exposures) is both an alternative and 

complementary strategy to vaccination. 

Live attenuated viral vaccines are contraindicated in pregnant women because 

of the hypothetical risk of harm should vaccine virus replication occur in the 

fetus. If a live attenuated viral vaccine is inadvertently given to a pregnant 

woman, or if a woman becomes pregnant within 28 days of vaccination, she 

should be counselled about the potential for adverse effects, albeit extremely 

unlikely, to the fetus (see also 4.18 Rubella and 4.22 Varicella). There is, however, 

no indication to consider termination of a pregnancy if a live attenuated vaccine 

has been inadvertently given. The live attenuated yellow fever vaccine is not 

recommended in pregnant women; however, where travel to a yellow fever risk 

country is unavoidable, the risks and benefits of yellow fever vaccination, and 

other strategies to mitigate the risk of acquiring yellow fever, should be discussed 

(see 4.23 Yellow fever). 

Inadvertent receipt of a vaccine contraindicated in pregnancy can be reported 

to the Therapeutic Goods Administration (TGA). For mechanisms for reporting 

to the TGA, see 2.3.2 Adverse events following immunisation. Post-marketing 

studies of pregnancy outcomes following vaccine administration are important 

to understand the safety profile of vaccines in this setting. For this reason some 

vaccine manufacturers also operate pregnancy registries, specific for their 

products, that will accept reports of vaccines administered during pregnancy; for 

example, see information on the varicella vaccine registry in 4.22 Varicella. 



Table 3.3.1: Recommendations for vaccination in pregnancy (see also disease-specific chapters in Part 4) 

Vaccines routinely recommended in pregnancy 

Inactivated viral vaccines Recommendation Comments 

Influenza vaccine Recommended for all pregnant There is evidence from clinical trial data and observational studies 

women at any stage of pregnancy, that there is no increased risk of congenital defects or adverse effects 

particularly those who will be in the in the fetuses of women who are vaccinated against influenza in 

second or third trimester during the pregnancy. Influenza immunisation protects the mother, as pregnancy 

influenza season. 

increases her risk of severe influenza, and also protects her newborn 

baby in the first few months after birth (see 4.7 Influenza). 

Vaccines not routinely recommended in pregnancy 

Inactivated bacterial vaccines Recommendation Comments 

Diphtheria-, tetanus-, and pertussiscontaining 

vaccines (dTpa, dT) 

dTpa can be given to pregnant 

women in the third trimester as an 

alternative to post-partum dTpa (if 

a dose of dTpa has not been given in 

the previous 5 years). 


VACCINATION REQUIREMENTS 

Vaccination in the third trimester is an acceptable alternative to postpartum 

vaccination, for pregnant women who have not been given a 

dTpa dose within the previous 5 years. 15 Receipt of dTpa in the third 

trimester of pregnancy may be preferred when the risk of the mother 

and/or infant acquiring pertussis is high, such as for pregnant women 

in close contact with infants. Vaccination during pregnancy has the 

advantage of achieving more timely and high pertussis antibody 

responses in the mother and infant after birth, as compared with 

vaccination given post-partum or prior to conception. 

Tetanus- and diphtheria-containing vaccines have been used 

extensively in pregnant women, with no increased risk of congenital 

abnormalities in fetuses of women who were vaccinated during 

pregnancy. 16-18 

(See 4.12 Pertussis for more details.) 15 

Cholera (oral) vaccine Not routinely recommended There are limited data on the safety of oral cholera vaccine in 

pregnancy. 19




Haemophilus influenzae type b (Hib) 

vaccine 

Meningococcal conjugate vaccines 

(MenCCV or 4vMenCV) 

Meningococcal polysaccharide vaccine 

(4vMenPV) 

13-valent pneumococcal conjugate 

vaccine (13vPCV) 

Not routinely recommended 

Can be given to pregnant women 

at increased risk of Hib disease (e.g. 

with asplenia) 



at increased risk of meningococcal 

disease (e.g. with asplenia) or 

as post-exposure prophylaxis 

in household contacts/cases of 

meningococcal serogroup A, C, W 135 

or Y 



at increased risk of meningococcal 

disease who have not been 

vaccinated with 4vMenPV in the 

past 3 years (e.g. with asplenia), 

or as post-exposure prophylaxis 

in household contacts/cases of 

meningococcal serogroup A, W 135 

or Y 

Limited available data suggest that it is unlikely that use of Hib 

vaccine in pregnant women has any deleterious effects on pregnancy 

outcomes. 20 

There are limited data on the safety of meningococcal conjugate 

vaccines in pregnancy. 21 Where clinically indicated, meningococcal 

conjugate vaccine can be given to pregnant women. 22 

Limited available data suggest that it is unlikely that use of 

meningococcal polysaccharide vaccine in pregnant women has 

any deleterious effects on pregnancy outcomes. 23,24 Where clinically 

indicated, meningococcal polysaccharide vaccine can be given to 

pregnant women, although 4vMenCV is preferred. 22 

Not routinely recommended No data are available. Vaccination during pregnancy has not been 

evaluated, although is unlikely to result in adverse effects.




23-valent pneumococcal polysaccharide 

vaccine (23vPPV) 


Can be given to pregnant women at 

the highest increased risk of invasive 

pneumococcal disease (IPD) (e.g. 

with asplenia, immunocompromise, 

cerebrospinal fluid leak) who have 

not received 23vPPV in the past 

5 years (and provided they have not 

received 2 previous doses) 



23vPPV has been administered in pregnancy in the context of clinical 

trials 25 with no evidence of adverse effects; however, data are limited. 

Where clinically indicated, 23vPPV can be given to pregnant women. 

Women of child-bearing age with known risk factors for IPD 

(including smokers) should be vaccinated before pregnancy, according 

to recommendations (see 4.13 Pneumococcal disease). 

Q fever vaccine Not routinely recommended Safe use in pregnancy has not been established. 

Typhoid Vi polysaccharide vaccine Not routinely recommended 


travelling to endemic countries 

where water quality and sanitation 

is poor 


Hepatitis A vaccine Not routinely recommended 

Can be given to susceptible pregnant 

women travelling to areas of 

moderate to high endemicity or 

those who are at increased risk of 

exposure through lifestyle factors, 

or where severe outcomes may be 

expected (e.g. pre-existing liver 

disease) 

No data are available. 26 Vaccination during pregnancy has not been 

directly evaluated, although is unlikely to result in adverse effects. 

Limited data are available. 

Hepatitis A vaccine should only be given to pregnant women who are 

non-immune and at increased risk for hepatitis A. 27




Hepatitis B vaccine Not routinely recommended 

Japanese encephalitis (JE) vaccine 

(JEspect) 

Can be given to susceptible pregnant 

women for whom this vaccine 

would otherwise be recommended, 

for example, as post-exposure 

prophylaxis in a non-immune 

pregnant women with a significant 

exposure to a HBsAg-positive source 



high risk of acquiring JE 

Poliomyelitis vaccine (IPV) Not routinely recommended 


high risk of poliovirus exposure (e.g. 

travel to endemic countries) 

Rabies vaccine Can be given to pregnant women for 

whom this vaccine would otherwise 

be recommended (e.g. post-exposure 

prophylaxis). 


Hepatitis B vaccine should only be given to pregnant women who are 

non-immune and at increased risk for hepatitis B. 28 


JE infection is associated with miscarriage, and women who are at 

high risk of JE should be assessed for the need for vaccination. Where 

the risk of JE disease is high, pregnant women should be vaccinated 

using the inactivated vaccine, JEspect (not Imojev, which is a live 

attenuated vaccine). 29 

Limited available data suggest that it is unlikely that use of 

inactivated poliomyelitis vaccine in pregnant women has any 

deleterious effects on pregnancy outcomes. 26 

IPV should only be given to pregnant women when clearly indicated. 

Limited available data suggest that it is unlikely that the use of rabies 

vaccine in pregnant women has any deleterious effects on pregnancy 

outcomes. 30-33 

Pregnancy is never a contraindication to rabies vaccination in 

situations where there is a significant risk of exposure (related to 

occupation or travel), or where there has been a potential exposure to 

rabies virus, Australian bat lyssavirus or another bat lyssavirus. 34,35


Vaccines not recommended in pregnancy 


Human papillomavirus (HPV) vaccine Not recommended Although HPV vaccination is not recommended during pregnancy, 

evidence from clinical trials and limited data from observational 

studies where HPV vaccine was inadvertently administered during 

pregnancy, indicate that there is no increased risk of adverse effects on 

the fetus. 36 

Live attenuated viral vaccines Recommendation Comments 



In the event of pregnancy, completion of a 3-dose course of 

vaccination should be deferred until after delivery. 

Yellow fever vaccine Not recommended Pregnant women should be advised against going to the rural areas 

of yellow fever endemic areas. However, where travel to an at-risk 

country is unavoidable, such women should be vaccinated. 37,38 Yellow 

fever vaccine has been given to a large number of pregnant women 

with no adverse outcomes. 39 

Vaccines contraindicated in pregnancy 

Live attenuated bacterial vaccines Recommendation Comments 

BCG vaccine Contraindicated There is only a hypothetical risk. BCG vaccine has not been shown to 

cause fetal damage. 40 

Oral typhoid vaccine Contraindicated There are limited data available (animal studies), suggesting no 

increased occurrence of fetal damage with oral live attenuated 

vaccine. 41 Inactivated typhoid Vi polysaccharide vaccine is preferred 

(see above). 


Japanese encephalitis (JE) vaccine 

(Imojev) 

Contraindicated There is only a hypothetical risk. There are currently no data available 

regarding the use of this vaccine in pregnant or breastfeeding women. 

Women of child-bearing age should avoid pregnancy for 28 days after 

vaccination.


Vaccines contraindicated in pregnancy 


Measles-mumps-rubella (MMR) Contraindicated There is only a hypothetical risk. Despite concerns that live attenuated 

vaccine 

rubella vaccine virus might cause congenital abnormalities, rubella 

or 

vaccine (either monovalent or as MMR) has been given to pregnant 

Measles-mumps-rubella-varicella 

women (usually inadvertently) without harm to the fetus. 

(MMRV) vaccine 

42,43 Even 

though rubella vaccine virus can infect the fetus, even for vaccine 

given in early pregnancy, there is no evidence that it causes congenital 

rubella syndrome in infants born to susceptible mothers. 44 Receipt 

of rubella vaccination during pregnancy is not an indication for 

termination. 43 


vaccination. 

It is recommended practice to test all pregnant women for immunity 

to rubella, and to vaccinate susceptible women as soon as possible 

after delivery and check their serological status post vaccination. 

Rotavirus vaccine Contraindicated Rotavirus vaccines are not registered or recommended for use in 

adolescents or adults. 

Varicella vaccine Contraindicated There is only a hypothetical risk. Congenital varicella syndrome has 

not been identified in women who have been inadvertently vaccinated 

with varicella vaccine in early pregnancy. 45 


vaccination. 

Zoster vaccine Contraindicated There is only a hypothetical risk. Women of child-bearing age are 

unlikely to be eligible for vaccination, as zoster vaccine is registered 

for use in persons ≥50 years of age. If women of child-bearing age 

have inadvertently been vaccinated, they should avoid pregnancy for 

28 days after vaccination.


Immunoglobulins for use as pre- or post-exposure prophylaxis 

Pooled or hyperimmune 

immunoglobulins 


Can be used post exposure in 

susceptible pregnant women 

exposed to: measles, hepatitis A, 

hepatitis B, rabies, Australian bat 

lyssavirus, or varicella viruses, or 

tetanus 




There is no known risk to the fetus from passive immunisation of 

pregnant women with immunoglobulins. 

For more details, see Part 5 Passive immunisation and relevant diseasespecific 

chapters in Part 4.

Contact between pregnant women and persons who have recently received live vaccines 

Household contacts of pregnant women should be age-appropriately vaccinated. 

It is safe to administer measles-, mumps-, rubella- and varicella-containing 

vaccines, zoster vaccine and rotavirus vaccine to the contacts of pregnant 

women. There is no risk of transmission of measles, mumps or rubella vaccine 

viruses from vaccinated household contacts. There is an almost negligible risk 

of transmission of varicella-zoster vaccine virus (from persons vaccinated with 

varicella or zoster vaccines); however, vaccine recipients with a varicella-like 

rash should be advised to cover the rash if in contact with a pregnant woman. 

Although there is a very small possibility of transmission of the rotavirus vaccine 

viruses to pregnant contacts, the benefit of immunising infants to protect against 

rotavirus disease and, in turn, reduce the risk of rotavirus in household contacts, 

far outweighs any theoretical risk (see 4.17 Rotavirus). 

Use of immunosuppressive therapy during pregnancy 

Certain immunosuppressive medications given for management of a medical 

condition in a woman during pregnancy (e.g. biological disease modifying 

anti-rheumatic drugs [bDMARDs]) may cross the placenta and be detectable 

in the infant, particularly if given during the third trimester. 46-48 In this setting, 

administration of live attenuated vaccines in the first few months of the infant’s 

life, particularly BCG vaccine, is not recommended. 49 (See also 4.20 Tuberculosis.) 

This is because of the risk that the infant’s immune response to vaccination may 

be reduced and potentially associated with increased vaccine virus/bacteria 

replication and related adverse effects. Although no specific time intervals 

are indicated, withholding BCG vaccine until the infant is 6 months of age is 

prudent. 50 Although there is some theoretical concern that a risk also applies 

to the administration of rotavirus vaccines, there are currently no data to 

substantiate this. 

Inactivated vaccines should be administered to these infants according to the 

recommended schedule. However, immune responses may be suboptimal. 

Additional inactivated vaccine doses may be required; expert advice should be 

sought regarding this. 

Breastfeeding and vaccination 

Vaccination is rarely contraindicated in breastfeeding women. The rubella 

vaccine virus may be secreted in human breast milk and there has been 

documented transmission to breastfed infants. However, where infection has 

occurred in an infant, the symptoms have been absent or mild. 51-53 Infants born 

to mothers who are hepatitis B surface antigen (HBsAg)-positive can also be 

breastfed, provided the infant is appropriately immunised at birth. Although 

studies have indicated the presence of hepatitis B virus (HBV) in the breast 

milk of mothers with HBV infection, breastfeeding poses no additional risk of 

virus transmission, compared with formula feeding, in vaccinated infants. 54 

Administration of yellow fever vaccine to breastfeeding women should be 


avoided, except in situations where the risk of acquiring yellow fever is high, 

and/or travel cannot be avoided or postponed. 55,56 While extremely rare, there 

have been several case reports of probable transmission of the yellow fever 

vaccine virus via breast milk. 55,56 For most vaccines, the immune response to 

vaccination of infants in relationship to breastfeeding has been studied and taken 

into account. In general, breastfeeding does not adversely affect immunisation, 

and breastfeeding is not a contraindication to the administration of any vaccines 

recommended in infants. 

Preterm infants 

Preterm (premature) infants are defined as those born at

doses after age 5 years. However, all children and adults who have chronic lung 

disease, or certain other chronic medical conditions, whether related to preterm 

birth or not, should also receive additional pneumococcal vaccine doses up to and 

beyond the age of 5 years (see 4.13 Pneumococcal disease). 

Hepatitis B vaccine 

Low-birth-weight preterm newborn infants do not respond as well to hepatitis 

B-containing vaccines as full-term infants. 69,74,75 Thus, for low-birth-weight 

infants (

3.3.3 Vaccination of immunocompromised persons 

A person can be immunocompromised due to disease and/or medical 

treatment. Vaccination of immunocompromised persons presents numerous 

challenges. The immune protection attained from previous immunisation 

may be diminished; the response to vaccines administered in the setting of 

immunocompromise may be reduced, with additional booster vaccine doses 

required; the risk of vaccine-preventable diseases and/or their complications 

may be increased; and the risk of adverse events from live vaccines may be 

increased. Degrees of immunocompromise vary from insignificant to profound, 

and this, together with the risk of acquiring vaccine-preventable disease, should 

be taken into account when considering a vaccination schedule. 

When considering vaccination of persons on immunosuppressive therapy, it is 

particularly important to consider a number of factors, including the biologic 

target of the medication being used (mechanism and duration of effect on the 

immune system) as well as the consequence of using combination therapies 

(e.g. prednisolone and methotrexate), which can contribute to the nature, 

extent and length of immunocompromise. It is also important to know the 

anticipated duration of immunocompromise, whether due to therapy or the 

underlying disease (see also ‘Immunocompromise associated with corticosteroid 

administration’ below). In some instances, additional booster doses of vaccines 

may be required to optimise protection in immunocompromised persons 

(e.g. pneumococcal vaccines at diagnosis of haematological malignancy). 

To determine the need for booster doses, it may be useful to measure postvaccination 

antibody titres in selected groups in some circumstances, such as 

for adults or children who have received haematopoietic stem cell transplants 

(see ‘Haematopoietic stem cell transplant recipients’ below). Reliable serological 

testing is not readily available and/or validated to measure vaccine-induced 

immunity for all vaccines, and, in addition, results should be interpreted using 

standardised serological correlates. (See also 2.1.5 Catch-up, ‘Use of serological 

testing to guide catch-up vaccination’.) Expert advice should be sought if 

required. 

Many vaccine-preventable diseases are associated with an increased risk of 

morbidity and mortality in immunocompromised persons. Two important 

examples are influenza and invasive pneumococcal disease (IPD). Annual 

influenza vaccination should be given to all immunocompromised persons 

≥6 months of age (see 4.7 Influenza). Immunocompromised persons may 

also require additional doses of pneumococcal vaccines; the timing, number 

of doses and type of vaccine(s) vary depending on age and the underlying 

risk for IPD (see 4.13 Pneumococcal disease). These, and other specific vaccine 

recommendations, are discussed in more detail below. 

All immunocompromised persons, irrespective of age, who receive influenza 

vaccine for the first time are recommended to receive 2 vaccine doses, at least 

4 weeks apart, and 1 dose annually thereafter (see 4.7 Influenza). Where it is 




known that a new influenza vaccine strain is circulating in the community to 

which cross-protective immunity in the population is low (such as in the setting 

of an influenza pandemic), it may be appropriate that immunocompromised 

persons receive 2 doses of inactivated influenza vaccine, a minimum of 4 weeks 

apart, to achieve an optimal immune response. For example, in the 2009–2010 

H1N1 global influenza pandemic it was shown that seroconversion to influenza 

vaccination in immunocompromised adolescents and adults was improved 

following receipt of 2 vaccine doses. 77 Further information and annual influenza 

vaccine recommendations are available on the Immunise Australia website 

(www.immunise.health.gov.au). 

The recommendations in this section for the use of vaccines in 

immunocompromised persons have been divided where applicable into 

paediatric (0–18 years) and adult (≥19 years) recommendations. This distinction 

has been made on the basis of scientific evidence, where available, and to assist in 

vaccine delivery in paediatric and adult special risk settings. 

Immunocompromise associated with corticosteroid administration 

The dose and duration of therapy with corticosteroids determines the impact 

on the immune system. In adults, daily doses of oral corticosteroids in excess of 

60 mg of prednisolone (or equivalent) for more than 1 week are associated with 

significant immunocompromise. In children, doses in excess of either 

2 mg/kg per day for more than 1 week or 1 mg/kg per day for more than 

4 weeks are associated with significant immunocompromise. Live attenuated 

vaccines are generally contraindicated in such persons (see also below). In 

addition, for both children and adults, even lower doses may be associated with 

some impairment of the immune response. 78 It is also important, once treatment 

with corticosteroids is ceased, to assess whether the person has other underlying 

immunocompromising disease or is receiving other immunosuppressive therapy 

that may influence decisions about whether vaccines, particularly live vaccines, 

can be given. 

For adults treated with systemic corticosteroids in excess of 60 mg per day for 

more than 1 week, live attenuated viral vaccines (such as MMR, MMRV, zoster, 

varicella and yellow fever vaccines) should be postponed until at least 1 month 

after treatment has stopped. 

Children receiving >2 mg/kg per day or ≥20 mg per day in total of prednisolone 

(or equivalent) for more than 1 week should not receive live attenuated vaccines 

until after corticosteroid therapy has been discontinued for at least 1 month. 

Children on daily doses of ≤2 mg/kg per day of systemic corticosteroids for 

less than 1 week, and those on lower doses of 1 mg/kg per day or alternateday 

regimens for periods of up to 4 weeks, may be given live attenuated viral 

vaccines. Some experts suggest withholding lower doses of steroids 2 to 3 weeks 

prior to vaccination with live viral vaccines if this is possible. 79,80 


Use of live viral or live bacterial vaccines in immunocompromised persons 

There is a risk that the administration of live vaccines to immunocompromised 

persons may result in adverse events or vaccine-related disease due to 

unchecked infection (replication) of the vaccine virus or bacteria. This is 

particularly so for measles-, mumps-, rubella-81,82 and VZV-containing 

(varicella and zoster) vaccines 83 and for bacille Calmette-Guérin (BCG) 

vaccine. 49,84 However, the risk of disease varies by vaccine and by individual. 

Caution is required for vaccination in the setting of immunocompromise, 

and in significantly immunocompromised persons most live vaccines are 

contraindicated. 

The following is a list of current recommendations for use of live vaccines in 

immunocompromised persons. 

• Tuberculosis vaccine (BCG) is always contraindicated. 

• Live vaccines, such as MMR- and VZV-containing (varicella and zoster) 

vaccines, should not be given to persons with severe immunocompromise. 

Severely immunocompromised persons include those who have active 

leukaemia or lymphoma, generalised malignancy, aplastic anaemia, 

graft-versus-host disease or congenital immunodeficiency. Others in 

this category include persons who have received recent chemotherapy, 

persons who have had solid organ or bone marrow transplants (within 

2 years of transplantation) or transplant recipients who are still taking 

immunosuppressive drugs, or others on highly immunosuppressive therapy, 

including high-dose corticosteroids (see above). Dependent on their age, 

persons infected with human immunodeficiency virus (HIV) with CD4 + cell 

counts of

• Yellow fever vaccine is generally contraindicated in immunocompromised 

travellers going to yellow fever endemic countries. The vaccine can, however, 

be considered on a case-by-case basis, including in persons with HIV (see 

4.23 Yellow fever). 

If there is uncertainty around the level of immunocompromise and when vaccine 

administration may be safe, this should be discussed with the treating physician 

and expert advice should be sought (see also ‘Immunocompromise associated 

with corticosteroid administration’ above). 

Household contacts of immunocompromised persons 

To best protect immunocompromised persons, whether adults or children, their 

household and other close contacts should be fully vaccinated according to 

current recommendations. Annual influenza vaccination is recommended for 

all household contacts (≥6 months of age) of immunocompromised persons. 

Assessment of the need for household contacts of immunocompromised persons 

to receive pertussis-containing and/or varicella vaccines is also very important 

(see 4.12 Pertussis and 4.22 Varicella). 85-87 

The use of live attenuated viral vaccines in contacts of immunocompromised 

persons (MMR, MMRV, varicella and rotavirus vaccines, where indicated) is 

safe, and strongly recommended to reduce the likelihood of contacts infecting 

the immunocompromised person. Persons ≥50 years of age who are household 

contacts of an immunocompromised person are also recommended to receive 

zoster vaccine. Although there is no risk of transmission of the MMR vaccine 

viruses, and an almost negligible risk of transmission of varicella-zoster vaccine 

virus (from varicella or zoster vaccine), there is a small risk of transmission of the 

rotavirus vaccine virus. Hand washing and careful disposal of soiled nappies is 

recommended to minimise transmission. Immunocompromised persons should 

avoid contact with persons with varicella and herpes zoster, where possible. (See 

also 4.9 Measles, 4.17 Rotavirus, 4.22 Varicella and 4.24 Zoster). 

Oncology patients 

Paediatric and adult patients undergoing cancer chemotherapy who have not completed a 

primary vaccination schedule before diagnosis 

Live vaccines, including BCG, MMR, zoster and varicella vaccines, are 

contraindicated in cancer patients receiving immunosuppressive therapy and/or 

who have poorly controlled malignant disease. These vaccines are recommended 

to be administered to seronegative persons at least 3 months after completion 

of chemotherapy, provided the underlying malignancy is in remission. 88 

Administration of live attenuated viral vaccines (MMR-containing or varicellacontaining 

vaccines) should be deferred if blood products or immunoglobulins 

have been recently administered (see Table 3.3.6 Recommended intervals between 

either immunoglobulins or blood products and MMR, MMRV or varicella vaccination). 


Influenza vaccination is recommended annually in all cancer patients aged 

≥6 months. All immunocompromised persons, irrespective of age, who receive 

influenza vaccine for the first time are recommended to receive 2 vaccine doses, 

at least 4 weeks apart, and 1 dose annually thereafter. 

Persons receiving chemotherapy may receive inactivated vaccines (e.g. 13vPCV, 

hepatitis B) according to a routine or catch-up vaccination schedule. The immune 

response may be suboptimal, but the vaccines are safe to administer. 

Vaccines should not be administered during times of severe neutropenia 

(absolute neutrophil count

• varicella vaccine: persons who are seronegative to varicella-zoster virus 

(VZV) should receive a 2-dose schedule of varicella vaccine, at least 6 months 

after chemotherapy has ceased (see 4.22 Varicella). 

Measles and rubella antibody status should be checked 6 to 8 weeks after 

vaccination with MMR or MMRV vaccine. Persons who have not seroconverted 

should receive a further dose. 

Administration of live attenuated viral vaccines (MMR-containing or varicellacontaining 

vaccines) should be deferred if blood products or immunoglobulins 

have been recently administered (see Table 3.3.6 Recommended intervals between 

either immunoglobulins or blood products and MMR, MMRV or varicella vaccination). 

Solid organ transplant recipients 

For solid organ transplant (SOT) recipients, depending on the transplanted 

organ, and to prevent rejection, variable doses of immunosuppressive agents 

are required and may influence the effectiveness of vaccines. Where possible, 

children undergoing solid organ transplantation should be vaccinated well 

before transplantation. Inactivated vaccines can be administered safely after 

transplantation, but are usually administered from 6 months after transplantation 

to maximise the immune response. 94,95 Live vaccines are contraindicated in 

most post-transplantation protocols due to concerns of disseminated infection, 

although data in this population are limited. 95-97 Recommended vaccinations for 

child and adult SOT recipients are given in Table 3.3.2. 



Table 3.3.2: Recommendations for vaccinations for solid organ transplant (SOT) recipients 96,98 

Vaccine Vaccines recommended before 

transplantation 

Child 

(0–18 years) 

Adult 

(≥19 years) 

Streptococcus pneumoniae (pneumococcal disease) 

13-valent 

pneumococcal 

conjugate vaccine 

(13vPCV) 

23-valent 

pneumococcal 


vaccine 

(23vPPV) 

Yes (aged 

≥6 weeks) 

Yes (≥8 weeks 

after 13vPCV) 



Vaccines recommended after 

transplantation, if not given 

beforehand 

Child 

(0–18 years) 

Yes Yes (aged 

≥6 weeks) 


after 13vPCV) 


after 13vPCV) 

Adult 

(≥19 years) 

Comment 

Yes Recommendations depend on age. See 4.13 

Pneumococcal disease and Table 2.1.11 Catch-up schedule 

for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) 

in children with a medical condition(s) associated with an 

increased risk of IPD, presenting at age




Child 

(0–18 years) 

Adult 

(≥19 years) 



beforehand 

Child 

(0–18 years) 

Adult 

(≥19 years) 

Comment 

Influenza 

Influenza vaccine Annual vaccination starting before transplantation for those ≥6 months of age. Two doses of influenza vaccine at least 4 weeks 

apart are recommended for all SOT recipients receiving influenza vaccine for the first time. Influenza vaccine should be given 

annually thereafter. 

Poliomyelitis 

IPV Yes Yes (see 

comments) 

Hepatitis B 

Hepatitis B vaccine Yes Yes, depending 

on serological 

status 

Yes Yes (see 

comments) 

Yes Yes, depending on 

serological status 

Hepatitis A 

Hepatitis A vaccine* Yes, if 

Yes, if 

Yes, if 

Yes, if 

seronegative (see seronegative (see seronegative (see seronegative (see 

comments) comments) comments) comments) 

Adults who have received a routine course of polio 

vaccination in childhood are recommended to receive 

a booster every 10 years if they plan to travel to a 

polio endemic area or have an occupational risk of 

polio exposure (e.g. laboratory workers). 

Recommended for all seronegative SOT candidates. 

Immunogenicity is likely to be improved when 

vaccination is administered before transplantation. 

Accelerated schedules can be used (see Table 4.5.2 

Accelerated hepatitis B vaccination schedules (for persons 

with imminent risk of exposure)). 

Recommended for all liver SOT recipients, or 

transplant candidates or recipients with chronic liver 

disease, or those chronically infected with either 

hepatitis B or hepatitis C.




Child Adult 

(0–18 years) (≥19 years) 

Neisseria meningitidis (meningococcal disease) 





beforehand 

Child Adult 

(0–18 years) (≥19 years) 

Comment 

Meningococcal C Yes Not indicated Yes Not indicated If the 1st MenCCV dose is given before 12 months of 

conjugate vaccine age, a 2nd dose should be given at least 8 weeks later. 

(MenCCV) Give 4vMenCV, if clinically indicated (see below), 

once child is ≥12 months of age, and at least 8 weeks 

has elapsed since receipt of last MenCCV dose. 

Quadrivalent Yes, if ≥9 months Yes, if defined Yes, if ≥9 months Yes, if defined 4vMenCV as a 2-dose schedule is recommended as a 

meningococcal of age with risk factors (see of age with risk factors (see primary course of vaccination for those (≥9 months of 

conjugate vaccine defined risk comments) defined risk comments) age) with complement component deficiencies (e.g. 

(4vMenCV)* factors (see 

comments) 

factors (see 

comments) 

Human papillomavirus 

HPV vaccine Yes Yes Yes, if no 

history of prior 

immunisation 

Measles, mumps and rubella 

MMR vaccine Yes Yes, unless 

2 previous 

documented 

doses 

Yes, if no 

history of prior 

immunisation 

C5-C9, properdin, Factor D, Factor H), functional 

hyposplenism or anatomical asplenia (see Table 

3.3.5 Recommendations for vaccination in persons with 

functional or anatomical asplenia). Boosters of 4vMenCV 

should be given every 5 years. 

3-dose schedule of 4vHPV is recommended for those 

aged >9 years. The routine schedule is 1st dose on day 

0 (day of vaccination), 2 months, and 6 months (after 

1st dose). Recommended in both females and males. 

For more detail, see 4.6 Human papillomavirus. 

Contraindicated Contraindicated The primary schedule should be completed before 

transplantation provided the transplant candidate is 

taking no immunosuppressive therapy and has no 

underlying cellular immunodeficiency.




Child 

(0–18 years) 

Varicella 

Varicella vaccine Yes, if nonimmune 

(see 

comments) 

Adult 

(≥19 years) 

Yes, if nonimmune 

(see 

comments) 



beforehand 

Child 

(0–18 years) 

Adult 

(≥19 years) 

Comment 

Contraindicated Contraindicated Confirm immunity with reliable history of varicella 

disease and confident clinical diagnosis or serological 

testing. 

The primary vaccination schedule should be 

completed before transplantation, provided the 

transplant candidate is taking no immunosuppressive 

therapy and has no underlying cellular 

immunodeficiency. 

* Any transplant recipient who anticipates travelling may require additional vaccination, such as for hepatitis A 

and meningococcal disease (see also 3.2 Vaccination for international travel).

Haematopoietic stem cell transplant recipients 99,100 

Haematopoietic stem cells are sourced from peripheral blood, bone marrow 

or umbilical cord blood. Protective immunity to vaccine-preventable diseases 

is partially or completely lost following either allogeneic or autologous stem 

cell transplantation. Immunocompromise following allogeneic transplantation 

is caused by a combination of the preparative chemotherapy given before 

transplantation, graft-versus-host disease (GVHD), and immunosuppressive 

therapy following transplantation. Persisting immunocompromise is common, 

particularly in persons with chronic GVHD. Immunity is also impaired in 

autologous HSCT recipients due to high-dose chemotherapy and radiotherapy, 

but GVHD is not a concern as donor stem cells are derived from the transplant 

recipient. In most cases, autologous HSCT recipients will recover their immunity 

more quickly than allogeneic transplant recipients. 

Separate vaccination schedules for autologous or allogeneic HSCT recipients 

have not been supported in published guidelines because of limited data. For 

practical purposes, the same schedule is recommended for these two groups, 

regardless of donor source (peripheral blood, bone marrow or umbilical cord), 

preparative chemotherapy (ablative or reduced intensity), or transplant type 

(allogeneic or autologous). 101,102 

HSCT recipients with ongoing GVHD or remaining on immunosuppressive 

therapy should not be given live vaccines. Chronic GVHD (cGVHD) is associated 

with functional hyposplenism and therefore increases susceptibility to infections 

with encapsulated organisms, especially Streptococcus pneumoniae. For persons 

with cGVHD who remain on active immunosuppression, antibiotic prophylaxis 

is recommended. 99 

The immune response to vaccinations is usually poor during the first 6 months 

after HSCT. Donor immunisation with hepatitis B, tetanus, Hib and 

pneumococcal conjugate vaccines before stem cell harvesting has been shown to 

elicit improved early antibody responses in HSCT recipients vaccinated in the 

post-transplantation period. 103-106 However, practical and ethical considerations 

currently limit the use of donor immunisation. 

Routine serological testing for several infectious agents and antibody levels 

conferring protective immunity are poorly defined. For those vaccines that 

are recommended for all HSCT recipients (tetanus, diphtheria, poliomyelitis, 

influenza, pneumococcal, Hib), pre-vaccination testing is not recommended as 

the response to a primary course of these vaccines is generally adequate. The 

serological response to pneumococcal vaccine is less predictable. Pneumococcal 

serology is only available in a few specialised laboratories and is not routinely 

recommended. Serology before and approximately 4 to 6 weeks after vaccination 

with the final dose of a hepatitis B vaccine course, and after MMR vaccine, is 

recommended as antibody levels will determine the need for revaccination. 102 

Post-vaccination varicella serology using commercial assays is very insensitive 

for vaccine-induced immunity (as compared with natural infection) and is not 

recommended (see 4.22 Varicella). 

A recommended schedule of vaccination is outlined in Table 3.3.3. 




Table 3.3.3: Recommendations for revaccination following haematopoietic 

stem cell transplant (HSCT) in children and adults, irrespective of 

previous immunisation history 99,100,107-111 

Vaccine Months after HSCT Comments 

6 8 12 24 

Streptococcus pneumoniae (pneumococcal disease) 

13-valent 

pneumococcal 

conjugate 

vaccine 

(13vPCV) 

23-valent 

pneumococcal 


vaccine 

(23vPPV) 

Yes Yes Yes Not needed See 4.13 Pneumococcal disease 

No No No Yes (after 

13vPCV) 


See 4.13 Pneumococcal disease 


Hib Yes Yes Yes Not needed 

Diphtheria, tetanus, pertussis 

DTPa-containing Yes Yes Yes Not needed For recipients

Vaccine Months after HSCT Comments 

6 8 12 24 

Neisseria meningitidis (meningococcal disease) 

Meningococcal 

C conjugate 

vaccine 

(MenCCV) 

(for those 

12 months post 

transplantation when 

a greater level of 

immune reconstitution 

has been achieved. 

Measles, mumps and rubella 

MMR vaccine No No No Yes, 1 or 

2 doses 

separated by 

a minimum 

interval of 

4 weeks (see 

comments) 

Varicella 

Varicella vaccine No No No Yes, 2 doses 

separated by 

a minimum 

interval of 

4 weeks (see 

comments) 

Not needed Two doses of 4vMenCV are 

recommended for persons 

≥12 months of age (see 4.10 

Meningococcal disease). 

Individual recommendations for 

HPV vaccination in those >9 years 

of age should be determined by an 

individual risk assessment (see 4.6 

Human papillomavirus). 

Give only if the person is off 

immunosuppressive therapy, with 

no cGVHD and with reconstituted 

cell-mediated immunity. Check 

serology 4 weeks after 1st vaccine 

dose. If there is no seroconversion, 

repeat the dose. 

Give to a seronegative recipient 

only if the person is off 

immunosuppressive therapy, with 

no cGVHD and with reconstituted 

cell-mediated immunity. 

* Any transplant recipient who anticipates travelling may require additional vaccination, such as 

for meningococcal and hepatitis A disease (see also 3.2 Vaccination for international travel). 




HIV-infected persons 112 

Vaccination schedules for HIV-infected persons should be determined by the 

person’s age, degree of immunocompromise (CD4 + count) and the risk of 

infection (see Table 3.3.4 below). Children with perinatally acquired HIV differ 

substantially from adults, as immunisation and first exposure to vaccine antigens 

occurs after HIV infection, whereas in adults, most vaccines are inducing a 

secondary ‘boosted’ immune response. HIV-infected persons of any age whose 

disease is well controlled on combination antiretroviral therapy (undetected or 

low viral load with good preservation of CD4 + lymphocyte count) are likely to 

respond satisfactorily to vaccines. 

Table 3.3.4: Categories of immunocompromise in HIV-infected persons, based 

on age-specific CD4 + counts and percentage of total lymphocytes 113 

depending on the number of vaccines received previously and evidence for 

seroconversion. Administration of MMR vaccine does not have a significant 

effect on the CD4 + count or viral load of HIV-infected adults. 121 Measles may 

cause severe disease in HIV-infected children, particularly those with a CD4 + 

count of 200 per µL, who are at a recognised risk of exposure; however, this 

should be discussed with the person’s treating clinician. 128 (See also 4.23 

Yellow fever and 3.2 Vaccination for international travel.) 

• BCG vaccine should not be given to HIV-infected children or adults because 

of the risk of disseminated BCG infection. 129,130 (See also 4.20 Tuberculosis.) 

• Oral live attenuated typhoid vaccines should be avoided in HIV-infected 

persons. Parenteral Vi polysaccharide typhoid vaccine should be used instead 

(see 4.21 Typhoid). 

Inactivated (non-live) vaccines 

• Diphtheria-tetanus-pertussis (DTPa/dTpa), Hib and IPV vaccines can be 

given according to routine recommendations112,131 (see relevant diseasespecific 

chapters in Part 4). 

• The 4vHPV vaccine can be given to children (≥9 years of age) and adults with 

HIV. It was safe and immunogenic in a small study of HIV1-infected men. 132 

HIV-infected persons should receive the routine course of 3 doses of 4vHPV 

vaccine at times 0, 2 and 6 months. Vaccination is recommended for persons 

in the age ranges for which the vaccine is registered (females aged 9–45 years 




and males 9–26 years); use of HPV vaccine in males up to the age of 45 years 

is unlikely to be associated with immunogenicity or adverse events that differ 

from those observed in females. However, the benefit of HPV vaccination 

is optimal when delivered to children or young adolescents prior to sexual 

debut (see 4.6 Human papillomavirus). 

• Pneumococcal disease, both respiratory and invasive (IPD), is a frequent 

cause of morbidity in HIV-infected children and adults (see List 4.13.1 in 

4.13 Pneumococcal disease). 133 Children should be vaccinated initially with 

pneumococcal conjugate vaccine (13vPCV); the number of doses depends 

on age at diagnosis and vaccination history (see Table 2.1.11 Catch-up 

schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with 

a medical condition(s) associated with an increased risk of IPD, presenting at age 

5 years and adults, a single dose of 13vPCV 

is recommended, followed by 23vPPV; repeat doses of 23vPPV are also 

indicated. See 4.13 Pneumococcal disease for details. 

• Annual influenza vaccination is recommended in all HIV-infected 

adults and children (≥6 months of age). In HIV-infected persons who are 

immunocompromised and children

Persons with functional or anatomical asplenia 

Persons with an absent or dysfunctional spleen are at a life-long increased risk 

of fulminant bacterial infection, most notably invasive pneumococcal disease 

(IPD). 89,141 Pneumococcal, meningococcal, Hib and influenza vaccination are 

particularly recommended for all persons with asplenia, whether functional 

or anatomical (such as splenectomy). Other vaccinations should be up to 

date. Vaccines should be provided according to the person’s age and previous 

immunisation history, and immunisation status should be reviewed regularly. 142 

Specific vaccine recommendations for persons with asplenia are discussed below 

and shown in Table 3.3.5. 

In persons undergoing an elective splenectomy, vaccination should be completed, 

where possible, 2 weeks before the scheduled operation date. In an unplanned 

splenectomy, vaccination should commence approximately 1 week after the 

splenectomy has occurred. 143 

Children with splenic dysfunction should also be given antibiotic prophylaxis to 

prevent bacterial infection, until at least 5 years of age. 144,145 All asplenic persons 

and/or their parents/carers should also be educated about the importance 

of early investigation and treatment of febrile illnesses, including the use of 

emergency antibiotics. Asplenic persons are recommended to wear a medical 

alert. Vaccination cannot provide protection against all bacterial infections, 

or even all pneumococcal serotypes that cause IPD, hence it is particularly 

important that persons with asplenia are informed of the life-long increased risk 

of severe bacterial infection, even if they have been appropriately vaccinated. 

Pneumococcal vaccination 

Additional doses of pneumococcal vaccine are recommended for persons with 

asplenia, depending on their age and previous immunisation history, as shown 

in Table 3.3.5. Detailed information is provided in 4.13 Pneumococcal disease and 

in Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 

23) in children with a medical condition(s) associated with an increased risk of IPD, 

presenting at age

4vMenCV is recommended from 12 months of age, instead of the routine NIPscheduled 

MenCCV vaccination; a 2nd dose of 4vMenCV should be given at 

least 8 weeks later. (See also 4.10 Meningococcal disease.) For adults and children 

who are >12 months of age at diagnosis, 2 doses of 4vMenCV are recommended, 

a minimum of 8 weeks apart. Subsequent booster doses of 4vMenCV are 

recommended at 5-yearly intervals thereafter. 

Hib vaccination 

A single dose of Hib vaccine is recommended for asplenic persons who were not 

vaccinated in infancy or who are incompletely vaccinated (see 4.3 Haemophilus 

influenzae type b and Table 2.1.8 Catch-up schedule for Hib vaccination for children 

Table 3.3.5: Recommendations for vaccination in persons with functional or 

anatomical asplenia 

Age Recommendations 

Pneumococcal vaccines 

6 weeks to 5 to

Age Recommendations 

Haemophilus influenzae type b (Hib) vaccine 

6 weeks–

Persons with autoimmune diseases and other chronic conditions 

Persons with autoimmune conditions, such as systemic lupus erythematosus 

(SLE), rheumatoid arthritis (RA) and multiple sclerosis (MS), are at higher 

risk of infections, including vaccine-preventable diseases, with the associated 

potential morbidity and mortality from infection. They are also at risk of 

infection due to treatment with immunosuppressive agents such as bDMARDs 

and targeted biological therapies. 148 Some diseases can be reactivated during 

therapy, so screening for infections such as hepatitis B and tuberculosis should be 

undertaken prior to vaccination. 149,150 

Overall, theoretical concerns that vaccines exacerbate or cause autoimmune 

diseases such as rheumatoid arthritis, type 1 diabetes and multiple sclerosis 

have not been substantiated, with sporadic case reports not verified by larger 

epidemiological studies. 151-154 However, persons with a history of Guillain-Barré 

syndrome (GBS) have an increased likelihood in general of developing GBS 

again, and the chance of them coincidentally developing the syndrome following 

influenza vaccination may be higher than in persons with no history of GBS. 

A small increased risk of GBS was associated historically with one influenza 

vaccine in the United States in 1976, but, since then, close surveillance has shown 

that GBS has occurred at a very low rate of up to 1 in 1 million doses of influenza 

vaccine, if at all. 155 

In persons with autoimmune diseases and other chronic conditions, 

there is potential for reduced immunogenicity of vaccines, due to both 

immunosuppressive therapies and the underlying disease. 156-158 The duration 

of immunocompromise may be prolonged and caution must be taken when 

considering live vaccines. Inactivated vaccines are recommended, to optimise 

protection despite the potential for reduced immunogenicity in some people. 

Clinical and laboratory measures of disease activity, and the choice, duration 

and dose of immunosuppressive therapies, do not always predict who will 

respond poorly to vaccination. 157,159,160 In some instances, due to ongoing risk 

of disease, additional vaccine doses may be required, such as pneumococcal 

vaccine. Inactivated vaccines such as HPV and dTpa can be administered to 

immunocompromised persons. Annual influenza vaccine is also important in 

this population and should be administered annually (2 doses in the first year, 

1 annually thereafter). 

Hypopituitarism is not a contraindication to vaccination if the person is only 

receiving physiological corticosteroid replacement, as this is not considered 

immunosuppressive. If the person has been unwell and is on high-dose 

corticosteroids for more than 1 week, the use of live attenuated vaccines should 

be delayed for a minimum of 1 month. 

Persons with metabolic diseases should be vaccinated using the routine schedule, 

as vaccinations are generally considered safe in these persons. 161 Influenza and 

pneumococcal vaccines are recommended for those with metabolic disease. Any 

individual concerns should be discussed with the treating metabolic physician. 




3.3.4 Vaccination of recent recipients of normal human 

immunoglobulin and other blood products 

The immune response to live parenteral viral vaccines (with the exception 

of yellow fever and zoster vaccine) may be inhibited by normal human 

immunoglobulin (NHIG). The interval recommended is dependent on the type 

and half-life of the immunoglobulin administered (see Table 3.3.6 Recommended 

intervals between either immunoglobulins or blood products and MMR, MMRV or 

varicella vaccination). 

Rotavirus vaccine may be administered at any time before or after, or 

concurrently with, any blood product, including antibody-containing products, 

following the routinely recommended schedule for rotavirus vaccine among 

infants who are eligible for vaccination (see 4.17 Rotavirus). Minimal data are 

available on the impact of blood products on the immune response to the vaccine 

in these infants. Completing the full rotavirus vaccine series will optimise 

protection. 162 

Zoster vaccine can be given at any time before or after administration of 

immunoglobulin, or any antibody-containing blood product, because those 

for whom it is registered (persons ≥50 years of age) are assumed to have had 

a previous VZV infection and, therefore, already have serum antibody levels 

comparable to those found in blood products (see 4.24 Zoster). 

In persons with agammaglobulinaemia who are receiving monthly NHIG, 

the use of live vaccines is not recommended as the immune response may be 

inhibited. In addition, these people will have sufficient circulating antibody 

(e.g. measles, varicella) from the NHIG to protect them in the case of exposure. 

Inactivated vaccines are recommended as per the routine schedule; the response 

may be suboptimal, but these vaccines are safe to administer. 

Persons, who have received a blood transfusion, including mass blood 

transfusions, do not require any past vaccinations to be repeated. However, 

following the receipt of any blood product, including plasma or platelets, an 

interval of 3 to 11 months should elapse, dependent on the blood product 

transfused, before vaccination with an MMR, MMRV or varicella vaccine (see 

Table 3.3.6 Recommended intervals between either immunoglobulins or blood products 

and MMR, MMRV or varicella vaccination). An interval is suggested because there 

may be low levels of antibodies present in the blood product that may impair the 

immune response to the live vaccine. 


Table 3.3.6: Recommended intervals between either immunoglobulins or blood 

products and measles-mumps-rubella (MMR), measles-mumpsrubella-varicella 

(MMRV) or varicella vaccination* 163 

Immunoglobulin/blood product Route Dose Interval 

(months) 

IU or mL Estimated 

mg IgG/kg 

Blood transfusion: 

Washed RBCs 

IV 

10 mL/kg 

Negligible 

RBCs, adenine-saline added IV 10 mL/kg 10 3 

Packed RBCs IV 10 mL/kg 20–60 5 

Whole blood IV 10 mL/kg 80–100 6 

Cytomegalovirus immunoglobulin IV 3 mL/kg 150 6 

HBIG as hepatitis B prophylaxis IM 100 IU 

400 IU 


0 

10 3 

NHIG (intravenous) for ITP treatment IV 400 8 

NHIG (intravenous) for ITP treatment IV 1000 10 

NHIG (intravenous) for ITP or 

Kawasaki disease treatment 

IV 1600–2000 11 

NHIG as hepatitis A prophylaxis IM 0.5 mL (50 kg) 

3 

NHIG as measles prophylaxis: 

(max. dose 15 mL) 

Standard 

IM 0.2 mL/kg 

5 

Immunocompromised IM 0.5 mL/kg 

6 

Plasma or platelet products IV 10 mL/kg 160 7 

HRIG as rabies prophylaxis IM 20 IU/kg 22 4 

Replacement (or therapy) of immune 

deficiencies (as NHIG [intravenous], 

various doses) 

IV 300–400 9 

Rh (D) IG (anti-D) IM 0 

TIG (IM use) for tetanus prophylaxis IM 250 IU (given 

within 24 hours 

of injury) 

500 IU (>24 hours 

after injury) 

ZIG as varicella prophylaxis IM 200 IU (0–10 kg) 

400 IU (11–30 kg) 

600 IU (>30 kg) 

* Zoster vaccine can be given at any time before or after administration of immunoglobulin or any 

antibody-containing blood product. 

10 

20 

3 

5 



3.3.5 Vaccination of persons with bleeding disorders 

Persons who are receiving anticoagulant therapy may develop haematomas in 

IM injection sites. The length of anticoagulant therapy should be clarified and 

immunisation delayed if therapy is going to be of short-term duration. Unless 

warfarin or low molecular weight heparin (LMWH) doses are known to be 

stable, persons receiving anticoagulants should have appropriate levels checked 

before vaccine administration, if possible. Intramuscular injections should be 

deferred if the INR is >2.0 (warfarin) or the anti-Xa (LMWH) level 4 hours post 

dose is >0.5 Units/mL. 

If a person has haemophilia and is receiving clotting factor replacement or similar 

therapy, IM vaccine administration should be conducted as soon as possible after 

the medication is received. 163 The site should not be rubbed post administration, 

but firm pressure applied for approximately 5–10 minutes. Vaccine recipients 

and/or carers should be informed about the possibility of haematoma formation. 

Ice and immobilisation may be used in the case of a small haematoma. The 

subcutaneous route could be considered as an alternative in a person with 

haemophilia or on anticoagulant therapy; however, the intramuscular route is 

preferred if that is the usual recommended mode of vaccine administration – 

seek expert advice. If a vaccine is administered subcutaneously, there may be 

diminished immune response (e.g. requirement to check anti-HBs antibodies) 

and additional vaccine doses may be required. 164,165 

3.3.6 Vaccination before or after anaesthesia/surgery 

Recent or imminent surgery is not a contraindication to vaccinations, and 

recent vaccination is not a contraindication to surgery (see 2.1.4 Pre-vaccination 

screening). There are no randomised controlled trials providing evidence of 

adverse outcomes with anaesthesia and surgery in recently vaccinated children. 

It is possible that the systemic effects from recent vaccination, such as fever and 

malaise, may cause confusion in the post-operative period. As the evidence 

is limited, it is possible to administer vaccines as per the routine schedule, 

or electively during a procedure for a person in a special risk group, if the 

appropriate vaccine delivery safety mechanisms are in place. 166 

If elective surgery and anaesthesia are to be postponed, some guidelines 

recommend postponing for 1 week after inactive vaccination and for 3 weeks 

after live attenuated viral vaccination in children. Routine vaccination may be 

deferred for 1 week after surgery. 167 

A person who receives any blood products during surgery will need to be 

informed of the need to delay some vaccinations (see Table 3.3.6 Recommended 

intervals between either immunoglobulins or blood products and MMR, MMRV or 

varicella vaccination). 


3.3.7 Vaccination of persons at occupational risk 

Certain occupations, particularly those associated with healthcare, are associated 

with an increased risk of some vaccine-preventable diseases. 168,169 Furthermore, 

some infected workers, particularly healthcare workers and those working in 

early childhood education and care, may transmit infections such as influenza, 

rubella, measles, mumps, varicella and pertussis to susceptible contacts, with 

the potential for serious health outcomes. Many infectious diseases, measles in 

particular, are highly infectious several days before symptoms become apparent. 

Healthcare workers employed within the public health system should check 

local state or territory healthcare worker immunisation requirements and the 

necessary documentation required (see Appendix 1 Contact details for Australian, 

state and territory government health authorities and communicable disease control). 

Where workers are at significant occupational risk of acquiring a vaccinepreventable 

disease, the employer should implement a comprehensive 

occupational vaccination program, which includes a vaccination policy, current 

staff vaccination records, provision of information about the relevant vaccinepreventable 

diseases, and the management of vaccine refusal (e.g. reducing 

the risk of a healthcare worker transmitting disease to vulnerable persons). 

Employers should take all reasonable steps to encourage non-immune workers to 

be vaccinated. 

Current recommended vaccinations for persons at risk of occupationally acquired 

vaccine-preventable diseases are listed in Table 3.3.7. In addition to the vaccines 

specific to a person’s occupation and work-related activities recommended here, 

all adults should be up to date with routinely recommended vaccines, such as 

dT-containing and MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.) 

Standard precautions should be adopted where there is risk of occupational 

exposure to blood and body fluids. Preventive measures include the appropriate 

handling and disposal of sharps, the donning of gloves when handling body 

fluids, and the use of goggles/face shields when splashes are likely. 

If a non-immune person is exposed to a vaccine-preventable disease, postexposure 

prophylaxis should be administered where indicated (see relevant 

disease-specific chapters in Part 4, and Part 5 Passive immunisation). 




Table 3.3.7: Recommended vaccinations for persons at increased risk of certain 

occupationally acquired vaccine-preventable diseases* † 

Occupation Vaccine 

Healthcare workers (HCW) 

All HCW 

Includes all workers and students directly involved in 

patient care or the handling of human tissues 

HCW who work in remote Indigenous communities 

or with Indigenous children in NT, Qld, SA and 

WA, and other specified healthcare workers in some 

jurisdictions 

HCW who may be at high risk of exposure to drugresistant 

cases of tuberculosis (dependent on state or 

territory guidelines) 

Persons who work with children 

All persons working with children, including: 

• staff and students working in early childhood 

education and care 

• correctional staff working where infants/ 

children cohabitate with mothers 

• school teachers (including student teachers) 

• outside school hours carers 

• child counselling services workers 

• youth services workers 


Hepatitis B 

Influenza 

MMR (if non-immune) ‡ 

Pertussis (dTpa) 

Varicella (if non-immune) 

Vaccines listed for ‘All 

HCW’, plus hepatitis A 

Vaccines listed for ‘All 

HCW’, plus consider BCG 

Influenza 


Pertussis (dTpa) 

Varicella (if non-immune) 

Staff working in early childhood education and care Vaccines listed for ‘Persons 

who work with children’, 

plus hepatitis A 

Carers 

Carers of persons with developmental disabilities § Hepatitis A 

Hepatitis B 

Influenza 

Staff of nursing homes and long-term care facilities for 

persons of any age § 

Influenza 


Varicella (if non-immune)


Providers of home care to persons at risk of high Influenza 

influenza morbidity 

Emergency and essential service workers 

Police and emergency workers Hepatitis B 

Influenza 

Tetanus (dT or dTpa) 

Armed forces personnel Hepatitis B 

Influenza 



Other vaccines relevant to 

deployment 

Staff of correctional facilities Hepatitis B 

Influenza 



Staff of detention and immigration centres Hepatitis B 

Influenza 



Laboratory personnel 

Laboratory personnel handling veterinary specimens Q fever 

or working with Q fever organism (Coxiella burnetii) 

Laboratory personnel handling either bat tissues or 

lyssaviruses (including rabies virus and Australian bat 

lyssavirus) 

Laboratory personnel routinely working with these 

organisms: 

Bacillus anthracis 

Vaccinia poxviruses 

Poliomyelitis virus 

Salmonella enterica subspecies enterica 

serovar Typhi (S. Typhi) 

Yellow fever virus 

Neisseria meningitidis 

Japanese encephalitis virus 

Rabies 

Anthrax 

Smallpox 

Poliomyelitis (IPV) 

Typhoid 

Yellow fever 

Quadrivalent 

meningococcal conjugate 

vaccine (4vMenCV) 






Persons who work with specific communities 

Workers who live with, or make frequent visits to, 

remote Indigenous communities in NT, Qld, SA and WA 


Hepatitis A 

Workers assigned to the outer Torres Strait Islands for Japanese encephalitis 

a total of 30 days or more during the wet season 

Persons who work with animals 

Veterinarians, veterinary students, veterinary nurses # Influenza 

Q fever 

Rabies 

Agricultural college staff and students (aged >15 

years) exposed to high-risk animals # 

Q fever 

Abattoir workers and contract workers in abattoirs 

(excluding pig abattoirs) 

Livestock transporters 

Sheep shearers and cattle, sheep and dairy farmers 

Those culling or processing kangaroos or camels 

Tanning and hide workers 

Goat farmers 

Livestock saleyard workers 

Those handling animal products of conception 

Wildlife and zoo workers who have contact with atrisk 

animals, including kangaroos and bandicoots 

Persons who come into regular contact with bats 

(both ‘flying foxes’ and microbats), bat handlers, bat 

scientists, wildlife officers, zoo curators 

Q fever 

Q fever 

Rabies 

Poultry workers and others handling poultry, 

Influenza 

including those who may be involved in culling 

during an outbreak of avian influenza, and swine 

industry workers 

Other persons exposed to human tissue, blood, body fluids or sewage 

Embalmers Hepatitis B 

Workers who perform skin penetration procedures Hepatitis B 

(e.g. tattooists, body-piercers) 

Funeral workers and other workers who have regular 

contact with human tissue, blood or body fluids and/ 

or used needles or syringes 

Plumbers or other workers in regular contact with 

untreated sewage 

Hepatitis B 

Hepatitis A 


* Work activities, rather than job title, should be considered on an individual basis to ensure an 

appropriate level of protection is afforded to each worker. In addition to providing protection

against certain vaccine-preventable diseases that persons in these occupations may be at 

increased risk of acquiring, vaccination may also reduce the risk of transmission of diseases to 

others with whom these persons are in contact. 

† In addition to the vaccines specific to a person’s occupation and work-related activities 

recommended here, all adults should be up to date with routinely recommended vaccines, such 

as dT-containing and MMR vaccines (see also Table 2.1.12 in 2.1.5 Catch-up). 

‡ All adults born during or since 1966 should have evidence of either receiving 2 doses of MMR 

vaccine or having immunity to measles, mumps and rubella. Adults born before 1966 are 

considered to be immune due to extensive measles, mumps and rubella circulating widely in 

the community during this period of time (see 4.9 Measles). 

§ Carers of infants

If a child is ≥12 months of age, the 1st doses of DTPa, hepatitis B, IPV, MMR, 

MenCCV, 13vPCV and Hib vaccines can be given at the same visit. For details, 

see 2.1.5 Catch-up. 

Migrant/refugee adults also need to be targeted for vaccination, especially 

against rubella, using MMR vaccine. This is particularly important for women 

of child-bearing age. Some refugees aged between 9 months and 30 years may 

have been offered MMR as part of a pre-departure screening, but may require a 

subsequent dose on arrival in Australia. 170 It is important to take into account any 

live attenuated viral vaccines that may have been administered as part of a predeparture 

screening, such as measles-containing vaccines or yellow fever vaccine 

(especially in those persons arriving from central and northern African nations). 

It is important to allow a minimum 4-week interval before administering any 

other live attenuated viral vaccines. 

All vaccines administered to children

3.3.11 Vaccination of persons who inject drugs 

Persons who inject drugs are at risk of acquiring hepatitis A and hepatitis B, 

and should be vaccinated against these infections (see 4.4 Hepatitis A and 

4.5 Hepatitis B). In addition, persons who inject drugs should be up to date 

with routinely recommended vaccines for adults, such as dT-containing and 

MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.) 

3.3.12 Vaccination of sex industry workers 

Sex industry workers are at risk of acquiring hepatitis A and hepatitis B, 

and should be vaccinated against these infections (see 4.4 Hepatitis A and 

4.5 Hepatitis B). Human papillomavirus vaccine may also be indicated 

(see 4.6 Human papillomavirus). In addition, sex industry workers should be 

up to date with routinely recommended vaccines for adults, such as dTcontaining 

and MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.) 

References 






PART 4 VACCINE-PREVENTABLE DISEASES 

4.1 CHOLERA 

4.1.1 Bacteriology 

Vibrio cholerae is a motile, curved Gram-negative bacillus. Differences in the 

O antigens have led to the description of more than 150 serogroups, only two 

of which have been found to cause cholera. Cholera is caused by enterotoxinproducing 

V. cholerae of serogroups O1 and O139 (sometimes referred to as 

the ‘Bengal’ strain). Serogroup O1 includes two biotypes (classical and El Tor), 

each of which includes organisms of Inaba, Ogawa and Hikojima serotypes. 

The ability of V. cholerae to persist in water is determined by the temperature, 

pH, salinity and availability of nutrients; it can survive under unfavourable 

conditions in a viable dormant state. 1 Transmission predominantly occurs when 

people ingest faecally contaminated food or water. 

4.1.2 Clinical features 

Cholera is an acute bacterial infection that is generally characterised by the 

sudden onset of painless, profuse, watery diarrhoea. In rare situations more than 

half the severe cases will die. Mild cases also occur, as does subclinical infection. 1 

The cholera toxin does not produce intestinal inflammation. The cholera toxin 

induces secretion of increased amounts of electrolytes into the intestinal lumen, 

resulting in mild to severe dehydration and, in some cases, metabolic acidosis. 

4.1.3 Epidemiology 

The disease is usually transmitted via food and water contaminated with human 

excreta. Seafood such as shellfish obtained from contaminated waters have 

also been responsible for outbreaks. 1 Cholera is a substantial health burden in 

developing countries and is considered to be endemic in Africa, Asia, South 

America and Central America. 2 Cholera epidemics are common in circumstances 

where food and water supplies can become contaminated, such as after natural 

disasters and civil unrest. 2 Cases of cholera in Australia (about 2 to 6 cases a 

year) almost always occur in individuals who have been infected in endemic 

areas overseas. 3 However, the overall risk of cholera to travellers with access to 

a safe water source and hygienic food preparation is considered to be low, even 

when visiting countries where cholera is endemic. The risk of infection has been 

estimated at 0.2 cases per 100 000 travellers from western countries, and the risk 

of severe disease is considerably lower, 4 although under-detection and underreporting 

of cholera among travellers is likely. 2,4,5 

In 1977, a locally acquired case led to the discovery of V. cholerae in some rivers 

of the Queensland coast. 6 Because of this, health workers should be aware that 

sporadic cases of cholera may, on rare occasions, follow contact with estuarine 


waters. All cases of cholera reported since the commencement of the National 

Notifiable Diseases Surveillance System in 1991 have been acquired outside 

Australia, except for 1 case of laboratory-acquired cholera in 1996 and 3 cases in 

2006. 3,7 The 3 cases in 2006, reported in Sydney, were linked and associated with 

consumption of raw imported whitebait. 7 These patients had no history of recent 

travel to known cholera-endemic areas. 7 


• Dukoral – CSL Limited and Crucell Sweden AB (inactivated wholecell 

V. cholerae O1, in combination with a recombinant cholera toxin 

B subunit [rCTB]). Each 3.0 mL liquid vaccine dose vial contains heat 

and formalin-inactivated Inaba, Ogawa, classic and El Tor strains of 

V. cholerae O1, 31.25 x 10 9 vibrios of each, combined with 1.0 mg rCTB. 

The buffer consists of a sachet of effervescent granules of anhydrous 

sodium carbonate, sodium bicarbonate, anhydrous citric acid, sodium 

citrate, saccharin sodium and raspberry flavour. This formulation 

does not contain aspartame. 

Trials of the oral cholera vaccine that contained inactivated whole-cell V. cholerae 

O1 combined with rCTB have been performed mainly in Bangladesh and Peru. 8-14 

The large randomised controlled trial in Bangladesh included over 120 000 

children (aged 2–15 years) and women (aged >15 years), with up to 5 years 

follow-up. About 13 000 children and 8 000 women received 3 doses of the study 

vaccine. When cholera cases in all age groups were aggregated, the protective 

efficacy of this vaccine (in a 3-dose regimen with inactivated Escherichia coli as 

control) was 85%, 6 months after the 3rd dose. The protective efficacy decreased 

to 62% after 1 year, and to 57% after 2 years. 8,10 On long-term follow-up (up to 

5 years) no significant protective efficacy was observed beyond 2 years. 8,14 The 

efficacy of the vaccine was lower and waned more rapidly in children aged 

2–5 years. 14 In this age group, while the efficacy was 100% during the first 

4–6 months after vaccination, it became non-significant in the latter half of the 

1st year of follow-up (during a cholera epidemic), resulting in an overall efficacy 

of 38% after 1 year; efficacy after 2 years was comparable. In contrast, for those 

aged >5 years, the efficacy estimates were 76%, 78% and 63%, respectively, at 

these three time points. 8,9,14 The protective efficacy of the vaccine, over a 3-year 

follow-up period, was not significantly different among those who received a 

total of 2 doses versus those who received 3 doses (including all ages). 8,9 

A randomised controlled trial in Peru among military recruits aged 16–45 years 

found a vaccine efficacy of 86% against symptomatic cholera after 2 vaccine 

doses. 13 Another Peruvian household study showed an overall efficacy of 61% 


4.1 CHOLERA

among 2–65-year olds, 12 after a booster dose given 10 months after a 2-dose 

primary series. 12 A field effectiveness case-control study in Mozambique, during 

a mass oral cholera vaccination program in an endemic population aged 

≥2 years, found that 1 or more doses of the inactivated oral cholera vaccine was 

78% protective (1–6 months after the 1st dose). The per-protocol effectiveness of 

2 doses was 84% (0.5–4.5 months after the 2nd dose). 15 

There is structural similarity and immunologic cross-reactivity between the 

cholera toxin and the heat-labile toxin of E. coli, which is often associated with 

‘travellers’ diarrhoea’. Therefore, it had been suggested that the rCTB-containing 

vaccine may also provide protection against heat-labile toxin producing 

enterotoxigenic E. coli (LT-ETEC). A study in short-term Finnish tourists16 showed that the inactivated oral cholera vaccine also provided a 60% reduction 

in diarrhoea caused by LT-ETEC. A study in Bangladesh, an endemic area, 

showed 67% protection against LT-ETEC for 3 months only. 17 It can be expected 

that the inactivated vaccine will reduce the proportion of travellers’ diarrhoea 

that is caused by LT-ETEC. Approximately 30 to 40% of travellers to developing 

countries contract travellers’ diarrhoea, with an average of 20% of cases caused 

by LT-ETEC; hence, the 60% efficacy of the oral inactivated vaccine against 

LT-ETEC could be expected to prevent up to 15% of travellers’ diarrhoea. 18-20 

However, in Australia this vaccine is only registered for the prevention of 

cholera. 

To date, there is no vaccine marketed in Australia to protect against infection 

with V. cholerae O139. An oral killed whole-cell bivalent cholera vaccine (against 

both serogroups O1 and O139) has been evaluated in Vietnam. 21,22 More recently, 

in India, an interim analysis of a cluster-randomised controlled trial reported a 

protective efficacy of 67% against V. cholerae O1 after 2 years. Specific efficacy 

against V. cholerae 0139 could not be assessed in this study, as cholera episodes 

caused by this serogroup were not detected. 23 

4.1.5 Transport, storage and handling 

Transport according to National vaccine storage guidelines: Strive for 5. 24 Store at 

+2°C to +8°C. Do not freeze. Protect from light. 

Because the person to be vaccinated will be responsible for looking after the 

vaccine following purchase, details of how it should be transported (from 

pharmacy to home) and stored in the refrigerator (at home) must be carefully 

explained. 

4.1.6 Dosage and administration 

Dukoral is an oral vaccine. 

Food and drink should be avoided for 1 hour before and 1 hour after 

administration of the inactivated cholera vaccine, as the vaccine is acid labile. 


Children aged 2–6 years 

Three doses are required, given a minimum of 1 week and up to 6 weeks apart. 

If an interval of more than 6 weeks occurs between any of the doses, re-start the 

vaccination course. 

Dukoral is administered orally. After dissolving the buffer granules in 150 mL 

of water, half the solution is then poured away and the entire contents of the 

vaccine vial are mixed with the remaining 75 mL for administration. 

Adults and children aged >6 years 

Two doses are required, given a minimum of 1 week and up to 6 weeks apart. If 

the 2nd dose is not administered within 6 weeks, re-start the vaccination course. 

Dukoral is administered orally. After dissolving the buffer granules in 150 mL 

of water, the contents of the vaccine vial are then added to the solution for 

administration. 

Co-administration with other vaccines 

The inactivated oral cholera vaccine can be given with, or at any time before or 

after, other travel vaccines, such as yellow fever or parenteral Vi polysaccharide 

typhoid vaccines. 

However, there should be an interval of at least 8 hours between the 

administration of the inactivated oral cholera vaccine and oral live attenuated 

typhoid vaccine (see 4.1.10 Precautions below). 

4.1.7 Recommendations 

Vaccination against cholera is not an official requirement for entry into any 

foreign country. 

Routine cholera vaccination is not recommended as the risk to travellers is 

very low, despite the endemicity of cholera in some countries often visited by 

Australians. Careful and sensible selection of food and water is of far greater 

importance to the traveller than cholera vaccination. 

Cholera vaccination should be considered for travellers at increased risk of 

acquiring diarrhoeal disease, such as those with achlorhydria, and for travellers 

at increased risk of severe or complicated diarrhoeal disease, such as those 

with poorly controlled or otherwise complicated diabetes, inflammatory bowel 

disease, HIV/AIDS or other conditions resulting in immunocompromise, or 

significant cardiovascular disease. 

Cholera vaccination should also be considered for travellers with considerable 

risk of exposure to, or acquiring, cholera, such as humanitarian disaster workers 

deployed to regions with endemic or epidemic cholera. 

Dukoral is not registered for use in children aged

Booster doses 

Booster doses are recommended for those who are at ongoing risk of exposure to 

cholera. 

Children aged 2–6 years who are at ongoing risk should receive a single booster 

dose 6 months after completion of the primary course. If the interval between 

primary immunisation and the booster dose is more than 6 months, primary 

immunisation must be repeated. 

Adults and children aged >6 years who are at ongoing risk should receive a 

single booster dose up to 2 years after completion of the primary course. If the 

interval between primary immunisation and the booster dose is more than 

2 years, primary immunisation must be repeated. 

4.1.8 Pregnancy and breastfeeding 

Cholera vaccine is not routinely recommended for pregnant or breastfeeding 

women. 

There is limited information on the use of inactivated oral cholera vaccines 

during pregnancy and breastfeeding. 25 

Refer to 3.3 Groups with special vaccination requirements, Table 3.3.1 

Recommendations for vaccination in pregnancy for more information. 

4.1.9 Contraindications 

The only absolute contraindications to cholera vaccine are: 

• anaphylaxis following a previous dose of the vaccine 

• anaphylaxis following any vaccine component. 

4.1.10 Precautions 

Postpone administration of cholera vaccine during either an acute febrile illness 

or acute gastrointestinal illness with persistent diarrhoea or vomiting, until 

recovered. 

Although the vaccine is not contraindicated in people who are 

immunocompromised, including those with HIV infection, data on effectiveness 

in this population are limited. 

There should be an interval of at least 8 hours between the administration of the 

inactivated oral cholera vaccine and oral live attenuated typhoid vaccine, as the 

buffer in the cholera vaccine may affect the transit of the capsules of oral typhoid 

vaccine through the gastrointestinal tract. 


4.1.11 Adverse events 

The inactivated oral cholera vaccine has a good safety profile, with similar 

rates of adverse events reported among vaccine and placebo clinical trial 

participants. 12,16,25 Mild abdominal pain, discomfort and diarrhoea were reported 

in post-marketing surveillance at a frequency of 0.1–1%. 26 

4.1.12 Public health management of cholera 

Cholera is a notifiable and quarantinable disease in all states and territories 

in Australia. 

Further instructions about the public health management of cholera, 

including management of cases of cholera and their contacts, should be 

obtained from state/territory public health authorities (see Appendix 1 

Contact details for Australian, state and territory government health authorities and 


4.1.13 Variations from product information 

The production information for Dukoral states that a booster dose is 

recommended for adults 2 years after the completion of the primary vaccine 

course if there is an ongoing risk of cholera. The ATAGI recommends that a 

booster dose is also recommended 2 years after the completion of the vaccine 

course for children >6 years of age if there is an ongoing risk of cholera. 

References 




4.1 CHOLERA

4.2 DIPHTHERIA 


Diphtheria is an acute illness caused by toxigenic strains of Corynebacterium 

diphtheriae, a Gram-positive, non-sporing, non-capsulate bacillus. The exotoxin 

produced by C. diphtheriae acts locally on the mucous membranes of the 

respiratory tract or, less commonly, on damaged skin, to produce an adherent 

pseudomembrane. Systemically, the toxin acts on cells of the myocardium, 

nervous system and adrenals. 


The incubation period is 2 to 5 days. The disease is communicable for up to 

4 weeks, but carriers may shed organisms for longer. Spread is by aerosol 

transmission or by direct contact with skin lesions or articles soiled by infected 

persons. The disease can involve almost any mucous membrane. Pharyngeal 

diphtheria, by far the commonest form of disease in the unimmunised, is 

characterised by an inflammatory exudate that forms a greyish or green 

membrane in the upper respiratory tract, which can cause acute severe 

respiratory obstruction. Life-threatening complications from diphtheria toxin 

include myocarditis and neuritis (usually affecting motor nerves). The casefatality 

rate in the last three decades has been reported as up to 16%. 1 Diphtheria 

antitoxin, which neutralises unbound toxin, was first used in the 1890s. Together 

with antibiotics, antitoxin is the mainstay of treatment for diphtheria, but this 

may not always be successful. The first death from diphtheria in Australia for 

over 20 years occurred in 2011 in an unvaccinated person. 2 Effective protection 

against diphtheria is only achieved by active immunisation with diphtheria 

toxoid-containing vaccines. 1,3 


In the early 1900s, diphtheria caused more deaths in Australia than any other 

infectious disease, but increasing use of diphtheria vaccines since World War II 

has led to its virtual disappearance. 4 The current epidemiology of diphtheria 

in Australia is similar to that in other developed countries. Almost all recent 

cases in the United Kingdom and the United States have been associated with 

imported infections. 5 In Australia, there have been two imported infections 

identified, one case in 2001 and one imported infection in 2011, resulting in 

two additional cases, including one death. 2,6 The 2011 fatal case of pharyngeal 

diphtheria occurred in an unvaccinated person infected by a friend who acquired 

diphtheria in a less developed country. 2 



Diphtheria toxoid is available in Australia only in combination with tetanus and 

other antigens. 

The acronym DTPa, using capital letters, signifies child formulations of 

diphtheria, tetanus and acellular pertussis-containing vaccines. The acronym 

dTpa is used for formulations that contain substantially lesser amounts 

of diphtheria toxoid and pertussis antigens than child (DTPa-containing) 

formulations; dTpa vaccines are usually used in adolescents and adults. 

Diphtheria vaccination stimulates the production of antitoxin, which protects 

against the toxin produced by the organism. The immunogen is prepared by 

treating a cell-free preparation of toxin with formaldehyde, thereby converting it 

into the innocuous diphtheria toxoid. Diphtheria toxoid is usually adsorbed onto 

an adjuvant, either aluminium phosphate or aluminium hydroxide, to increase 

its immunogenicity. Antigens from Bordetella pertussis, in combination vaccines, 

also act as an effective adjuvant. 

The circulating levels of antitoxin required for protection from diphtheria are 

well described. Antitoxin levels of 0.1 IU/mL are associated 

with more certain and prolonged protection. 7 Complete immunisation induces 

protective levels of antitoxin lasting throughout childhood, but, by middle age, 

at least 50% of persons not vaccinated since childhood have levels

• Infanrix IPV – GlaxoSmithKline (DTPa-IPV; diphtheria-tetanusacellular 

pertussis-inactivated poliovirus). Each 0.5 mL pre-filled 

syringe contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 

25 µg PT, 25 µg FHA, 8 µg PRN, 40 D-antigen units inactivated 

poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) 

and 32 D-antigen units type 3 (Saukett), adsorbed onto aluminium 

hydroxide; traces of formaldehyde, polysorbate 80, polymyxin and 

neomycin. 

• Pediacel – Sanofi Pasteur Pty Ltd (DTPa-IPV-Hib; diphtheria-tetanusacellular 

pertussis-inactivated poliovirus-Haemophilus influenzae type 

b). Each 0.5 mL monodose vial contains ≥30 IU diphtheria toxoid, 

≥40 IU tetanus toxoid, 20 µg PT, 20 µg FHA, 3 µg PRN, 5 µg pertussis 

fimbriae (FIM) 2+3, 40 D-antigen units inactivated poliovirus type 

1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen 

units type 3 (Saukett), 10 µg Hib capsular polysaccharide conjugated 

to 20 µg tetanus protein; 1.5 mg aluminium phosphate; ≤50 ng 

bovine serum albumin; phenoxyethanol as preservative; traces of 

formaldehyde, glutaraldehyde, polysorbate 80, polymyxin, neomycin 

and streptomycin. 

• Quadracel – Sanofi Pasteur Pty Ltd (DTPa-IPV; diphtheria-tetanusacellular 

pertussis-inactivated poliovirus). Each 0.5 mL monodose vial 

contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 20 µg PT, 

20 µg FHA, 3 µg PRN, 5 µg FIM 2+3, 40 D-antigen units inactivated 

poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 

32 D-antigen units type 3 (Saukett); 1.5 mg aluminium phosphate; 

≤50 ng bovine serum albumin; phenoxyethanol as preservative; traces 

of formaldehyde, glutaraldehyde, polysorbate 80, polymyxin and 

neomycin. 

• Tripacel – Sanofi Pasteur Pty Ltd (DTPa; diphtheria-tetanus-acellular 

pertussis). Each 0.5 mL monodose vial contains ≥30 IU diphtheria 

toxoid, ≥40 IU tetanus toxoid, 10 µg PT, 5 µg FHA, 3 µg PRN, 5 µg 

FIM 2+3; 1.5 mg aluminium phosphate; 3.4 mg phenoxyethanol. 

Reduced antigen formulations for adults, adolescents and 

children aged ≥10 years 

• ADT Booster – CSL Limited/Statens Serum Institut (dT; diphtheriatetanus). 

Each 0.5 mL monodose vial or pre-filled syringe contains 

≥2 IU diphtheria toxoid and ≥20 IU tetanus toxoid, adsorbed onto 

0.5 mg aluminium as aluminium hydroxide. 


• Adacel – Sanofi Pasteur Pty Ltd (dTpa; diphtheria-tetanus-acellular 


toxoid, ≥20 IU tetanus toxoid, 2.5 µg PT, 5 µg FHA, 3 µg PRN, 

5 µg FIM 2+3; 0.33 mg aluminium as aluminium phosphate; 

phenoxyethanol as preservative; traces of formaldehyde and 

glutaraldehyde. 

• Adacel Polio – Sanofi Pasteur Pty Ltd (dTpa-IPV; diphtheria-tetanusacellular 


or pre-filled syringe contains ≥2 IU diphtheria toxoid, ≥20 IU tetanus 

toxoid, 2.5 µg PT, 5 µg FHA, 3 µg PRN, 5 µg FIM 2+3, 40 D-antigen 

units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type 

2 (MEF-1) and 32 D-antigen units type 3 (Saukett); 0.33 mg aluminium 

as aluminium phosphate; phenoxyethanol as preservative; traces of 



• Boostrix – GlaxoSmithKline (dTpa; diphtheria-tetanus-acellular 

pertussis). Each 0.5 mL monodose vial or pre-filled syringe contains 

≥2 IU diphtheria toxoid, ≥20 IU tetanus toxoid, 8 µg PT, 8 µg FHA, 

2.5 µg PRN, adsorbed onto 0.5 mg aluminium as aluminium 

hydroxide/phosphate; traces of formaldehyde, polysorbate 80 and 

glycine. 

• Boostrix-IPV – GlaxoSmithKline (dTpa-IPV; diphtheria-tetanusacellular 


syringe contains ≥2 IU diphtheria toxoid, ≥20 IU tetanus toxoid, 8 µg 

PT, 8 µg FHA, 2.5 µg PRN, 40 D-antigen units inactivated poliovirus 

type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen 

units type 3 (Saukett), adsorbed onto 0.5 mg aluminium as aluminium 

hydroxide/phosphate; traces of formaldehyde, polysorbate 80, 

polymyxin and neomycin. 




Infanrix hexa must be reconstituted by adding the entire contents of the syringe 

to the vial and shaking until the pellet is completely dissolved. Reconstituted 

vaccine should be used as soon as practicable. If storage is necessary, hold at 

room temperature for not more than 8 hours. 


4.2 DIPHTHERIA


The dose of all diphtheria-containing vaccines is 0.5 mL, to be given by 

IM injection. 

Do not mix DTPa- or dTpa-containing vaccines or dT vaccine with any other 

vaccine in the same syringe, unless specifically registered for use in this way. 


Infants and children 

Diphtheria toxoid is given in combination with tetanus toxoid and acellular 

pertussis as DTPa vaccine. The recommended 3-dose primary schedule is at 2, 

4 and 6 months of age. The 1st dose can be given as early as 6 weeks of age, due 

to the high morbidity and occasional mortality associated with pertussis in very 

young infants. If the 1st dose is given at 6 weeks of age, the next scheduled doses 

should still be given at 4 months and 6 months of age (see 4.12 Pertussis). 

A booster dose of diphtheria-containing vaccine, usually provided as DTPa- 

IPV, is recommended at 4 years of age, but can be given as early as 3.5 years. 

For this booster dose, all brands of DTPa-containing vaccines are considered 

interchangeable. 

Where required, DTPa-containing vaccines can be given for catch-up for either 

the primary doses or booster dose in children aged

antibodies at an age when waning of diphtheria and tetanus immunity is 

commencing in the Australian population. 11 Diphtheria can be a significant risk 

for travellers to some countries (particularly Southeast Asia, New Guinea, the 

states of the former Soviet Union, Baltic countries or eastern European countries). 

Travellers to countries where health services are difficult to access should be 

adequately protected against diphtheria before departure. They should receive a 

booster dose of dT (or dTpa if not given previously) if more than 10 years have 

elapsed since the last dose of dT-containing vaccine. 

For persons undertaking high-risk travel, consider giving a booster dose of either 

dTpa or dT (as appropriate) if more than 5 years have elapsed since the last dose 

of a dT-containing vaccine. 

Primary vaccination 

Persons who have not received any diphtheria vaccines are also likely to 

have missed tetanus vaccination. Therefore, 3 doses of dT should be given at 

minimum intervals of 4 weeks, followed by booster doses at 10 and 20 years after 

the primary course. One of these 3 doses (preferably the 1st) should be given as 

dTpa, to also provide additional protection against pertussis. In the event that 

dT vaccine is not available, dTpa can be used for all primary doses. However, 

this is not recommended routinely because there are no data on the safety, 

immunogenicity or efficacy of dTpa in multiple doses for primary vaccination. 

For additional information on adults with no history of a primary course of dT 

vaccine requiring catch-up, see 2.1.5 Catch-up. 


Although dT or dTpa vaccines are not routinely recommended for pregnant 

women, they can be given under certain circumstances, such as for management 

of a tetanus-prone wound (see 4.19 Tetanus) or to prevent pertussis in pregnant 

women and their newborns (see 4.12 Pertussis). 14 

dT or dTpa vaccines can be given to breastfeeding women. 




The only absolute contraindications to diphtheria-containing vaccines are: 

• anaphylaxis following a previous dose of any diphtheria-containing vaccine 



Mild discomfort or pain at the injection site persisting for up to a few days is 

common. Uncommon general adverse events following dT vaccine include 

headache, lethargy, malaise, myalgia and fever. Anaphylaxis, urticaria and 

peripheral neuropathy occur very rarely. Brachial neuritis (inflammation of a 


4.2 DIPHTHERIA

nerve in the arm, causing weakness or numbness) has been described following 

the administration of tetanus toxoid-containing vaccines, with an estimated 

excess risk of approximately 0.5–1 in 100 000 doses in adults. 15,16 For specific 

adverse events following combination vaccines containing both diphtheria and 

pertussis antigens, see 4.12 Pertussis. 

4.2.11 Public health management of diphtheria 

Diphtheria is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of diphtheria, 

including management of cases of diphtheria and their contacts, should 

be obtained from state/territory public health authorities (see Appendix 1 



Confirmed or suspected diphtheria is of considerable public health importance 

and should be notified immediately to state/territory public health authorities. 

In general, contacts of a proven or presumptive diphtheria case will require 

vaccination (either primary or booster, depending on vaccination status), and 

appropriate prophylactic antibiotics17 (see 4.12 Pertussis). 

Advice should be sought with respect to diphtheria antitoxin access and 

dosage, and special arrangements made if hypersensitivity is suspected; this 

can be coordinated through the relevant state/territory health authority (see 


authorities and communicable disease control and Part 5 Passive immunisation). 


The product information for Infanrix hexa states that this vaccine is indicated 

for primary immunisation of infants from the age of 6 weeks. The ATAGI 

recommends that this vaccine may also be used for catch-up of the primary 

schedule in children

children aged

The product information for Boostrix, Boostrix-IPV, Infanrix hexa and 

Infanrix IPV states that these vaccines are contraindicated in children with 

encephalopathy of unknown aetiology or with neurologic complications 

occurring within 7 days following a vaccine dose. The ATAGI recommends 

instead that the only contraindication is a history of anaphylaxis to a previous 

dose or to any of the vaccine components. 

References 




4.3 HAEMOPHILUS INFLUENZAE TYPE B 


Haemophilus influenzae is a Gram-negative coccobacillus that is a normal part 

of upper respiratory tract flora. It can be isolated in two forms: capsular and 

non-capsular. Strains isolated from respiratory tract specimens, such as sputum 

and middle ear or sinus fluid, usually do not have a capsule, and are known 

as non-typeable Haemophilus influenzae (NTHi). Six capsular types (a to f) have 

been described and, before the introduction of vaccination against Haemophilus 

influenzae type b (Hib), almost all H. influenzae isolates from sterile sites (blood, 

cerebrospinal fluid, joint or pleural fluid) were of the b capsular type. 1 

Before Hib immunisation, invasive disease caused by Hib rarely occurred 

after the age of 5 years. This was because the prevalence of antibody to Hib 

progressively increased from the age of 2 years, thought to be related to exposure 

to Hib (or cross-reacting organisms) colonising the nasopharynx or other sites. 

Children

population. 5-7 The reduction in the incidence of Hib disease following routine 

vaccination has been particularly marked in Indigenous children, although 

absolute rates remain substantially higher than those in the non-Indigenous 

population. 8-10 Similar impressive reductions in Hib disease have been seen in 

other countries with routine childhood vaccination. 11,12 Since Hib disease has 

become relatively rare, cases of epiglottitis can no longer be assumed to be due 

to H. influenzae type b and, moreover, even when H. influenzae is isolated from 

a normally sterile site, it may not be type b. Thus, laboratory confirmation of 

H. influenzae infection and serotype should always be sought before vaccination 

failure is assumed. 13,14 


Four types of conjugate Hib vaccines have been developed, each containing the 

Hib capsular polysaccharide polyribosylribitol phosphate (PRP) conjugated to a 

different carrier protein. Of these, PRP-OMP (conjugated to the outer membrane 

protein of Neisseria meningitidis), PRP-T (conjugated to tetanus toxoid) and 

HbOC (conjugated to a mutant diphtheria toxoid) elicit antibody responses 

associated with protection of children against Hib. The fourth vaccine type, 

PRP-D (conjugated to diphtheria toxoid), was less immunogenic and found to be 

poorly protective in high-risk populations, such as Indigenous children. 15 PRP-T 

has subsequently been included in a number of combination vaccines, including 

DTPa-hepB-IPV-Hib and Hib-MenCCV. 

In Australia, the differing epidemiology of invasive Hib disease by ethnicity 

and region has determined the recommendations for Hib vaccine choice (see 3.1 

Vaccination for Aboriginal and Torres Strait Islander people). There have been four 

distinct eras of implementation of the Hib vaccination program for Australian 

children, which are described in detail elsewhere. 10 

Some Hib combination vaccines containing acellular pertussis are known to 

produce lower Hib antibody responses than similar formulations containing 

whole-cell pertussis. 16 When administered according to the United Kingdom’s 

schedule as 3 primary doses at 2, 3 and 4 months of age without a booster, their 

use has been associated with an increased risk of vaccine failure. 17 In other 

European countries that routinely give a 4th dose around the time of the 1st 

birthday, as Australia does, no loss of effectiveness has been observed. 18,19 

Monovalent Hib vaccines 

• Act-HIB – Sanofi Pasteur Pty Ltd (PRP-T). Lyophilised powder 

in a monodose vial with a pre-filled diluent syringe. Each 0.5 mL 

reconstituted dose contains 10 µg Hib capsular polysaccharide 

(polyribosyl-ribitol-phosphate [PRP]) conjugated to 18–30 µg 

tetanus protein. 


• Hiberix – GlaxoSmithKline (PRP-T). Lyophilised pellet in a monodose 

vial with separate diluent. Each 0.5 mL reconstituted dose contains 

10 µg Hib capsular polysaccharide (PRP) conjugated to 30 µg tetanus 

toxoid; lactose. 

• Liquid PedvaxHIB – CSL Limited/Merck & Co Inc (PRP-OMP). Each 

0.5 mL monodose vial contains 7.5 µg Hib capsular polysaccharide 

(PRP) conjugated to 125 µg Neisseria meningitidis outer membrane 

protein (OMP) complex; 225 µg aluminium as aluminium hydroxide; 

35 µg borax. 

Combination vaccines that contain Hib 

• Infanrix hexa – GlaxoSmithKline (DTPa-hepB-IPV-Hib; diphtheriatetanus-acellular 

pertussis-hepatitis B-inactivated poliovirus- 

Haemophilus influenzae type b [PRP-T]). The vaccine consists of both 

a 0.5 mL pre-filled syringe containing ≥30 IU diphtheria toxoid, 

≥40 IU tetanus toxoid, 25 µg pertussis toxoid (PT), 25 µg filamentous 

haemagglutinin (FHA), 8 µg pertactin (PRN), 10 µg recombinant 

HBsAg, 40 D-antigen units inactivated poliovirus type 1 (Mahoney), 

8 D-antigen units type 2 (MEF-1) and 32 D-antigen units type 3 

(Saukett), adsorbed onto aluminium hydroxide/phosphate; traces 

of formaldehyde, polysorbate 80, polysorbate 20, polymyxin and 

neomycin; and a vial containing a lyophilised pellet of 10 µg purified 

Hib capsular polysaccharide (PRP) conjugated to 20–40 µg tetanus 

toxoid. May contain yeast proteins. 

• Menitorix – GlaxoSmithKline (Hib-MenCCV; Haemophilus influenzae 

type b [PRP-T]-meningococcal serogroup C–tetanus toxoid conjugate). 

Lyophilised powder in a monodose vial with a pre-filled diluent 

syringe. Each 0.5 mL reconstituted dose contains 5 µg Hib capsular 

polysaccharide (PRP) conjugated to 12.5 µg tetanus toxoid, and 5 µg 

Neisseria meningitidis serogroup C polysaccharide conjugated to 5 µg 

tetanus toxoid; traces of trometamol and sucrose. 



b [PRP-T]). Each 0.5 mL monodose vial contains ≥30 IU diphtheria 


pertussis fimbriae (FIM) 2+3, 40 D-antigen units inactivated poliovirus 

type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 

32 D-antigen units type 3 (Saukett), 10 µg Hib capsular polysaccharide 

(PRP) conjugated to 20 µg tetanus protein; 1.5 mg aluminium 

phosphate; ≤50 ng bovine serum albumin; phenoxyethanol as 

preservative; traces of formaldehyde, glutaraldehyde, polysorbate 80, 

polymyxin, neomycin and streptomycin. 


4.3 HAEMOPHILUS 

INFLUENZAE TYPE B




Act-HIB must be reconstituted by adding the entire contents of the diluent syringe 

to the vial and shaking until the powder is completely dissolved. Reconstituted 

vaccine must be used immediately. 

Hiberix must be reconstituted by adding the entire contents of the diluent container 



+2°C to +8°C for not more than 24 hours. 





Menitorix must be reconstituted by adding the entire contents of the diluent 

syringe to the vial and shaking until the powder is completely dissolved. 

Reconstituted vaccine should be used as soon as practicable. If storage is 

necessary, hold at +2°C to +8°C for not more than 24 hours. 


The dose of all Hib-containing vaccines is 0.5 mL to be given by IM injection. 


All Hib-containing vaccines may be administered in separate sites on the same 

day as any of the other childhood vaccines such as pneumococcal conjugate, 

meningococcal serogroup C conjugate (MenCCV), hepatitis B, DTPa-containing 

and inactivated poliomyelitis vaccine (IPV) (or IPV-containing) vaccines. 

No or minimal immunologic interference has been observed when children are 

vaccinated with pneumococcal conjugate vaccines (7vPCV – Prevenar; 13vPCV 

– Prevenar 13; or 10vPCV – Synflorix) and PRP-T-containing hexavalent vaccine 

(Infanrix hexa) at the same immunisation visit. 21-24 

Interchangeability of Hib vaccines 

Where possible, the same brand of Hib-containing vaccine should be used for 

all primary doses. If different Hib-containing vaccines (i.e. PRP-OMP and PRP-T 

vaccines) are used in the primary series, then 3 doses (of any Hib-containing 

vaccine) are required at 2, 4 and 6 months of age, with a booster of a Hibcontaining 

vaccine at 12 months of age. For booster doses and in children 

>15 months of age, regardless of previous Hib vaccinations, a single dose of any 

Hib-containing vaccine is sufficient for protection. 



Infants 

A Hib-containing vaccine is recommended for all infants from 2 months of age. 

PRP-T-containing Hib vaccines require 3 primary doses, at 2, 4 and 6 months of 

age, followed by a booster dose at 12 months of age. Immunisation using PRP- 

OMP-containing Hib vaccine only requires 2 primary doses, at ages 2 and 

4 months, followed by a booster at 12 months of age. 

The 1st dose of a Hib-containing vaccine can be given as early as 6 weeks of age. 

If the 1st dose is given at 6 weeks of age, the next scheduled doses should still be 

given at 4 months and 6 months of age. 

Booster doses 

A single booster dose of Hib vaccine is recommended at 12 months of age 

(see ‘Infants’ above). This booster dose can be administered using either the 

monovalent Hib vaccine or, where meningococcal serogroup C vaccination is 

also scheduled, the combined Hib-meningococcal serogroup C conjugate vaccine 

(Hib-MenCCV). 

Children aged ≥15 months and up to 59 months of age at presentation who 

have not received a primary course of a Hib or Hib-containing vaccine will only 

require 1 dose of vaccine as catch-up, irrespective of the number of previous 

doses administered. There should be a minimum 2-month interval between their 

last dose and the catch-up dose. Catch-up for Hib vaccination for children up to 

59 months of age is outlined in Table 2.1.8 Catch-up schedule for Hib vaccination for 

children

according to the recommendations above and Table 2.1.8 Catch-up schedule for 

Hib vaccination for children

4.3.11 Public health management of invasive Hib disease 

Haemophilus influenzae type b is a notifiable disease in all states and territories 

in Australia. 

Further instructions about the public health management of Hib, including 

management of cases of invasive Hib disease and their contacts, should 









4.4 HEPATITIS A 

4.4.1 Virology 

Hepatitis A is an acute infection of the liver caused by the hepatitis A virus 

(HAV), a picornavirus (a small single-stranded RNA virus). 1 The virus survives 

well in the environment outside of the human host. It persists on hands for 

several hours and in food kept at room temperature for considerably longer, and 

is relatively resistant to heat and freezing. 


Hepatitis A is an infection of humans; there is no animal reservoir. 1 HAV is 

predominantly transmitted by the faecal–oral route. The infecting dose is 

unknown, but it is presumed to be low. The incubation period of hepatitis A is 15 

to 50 days, with a mean of about 28 days. 2 HAV is excreted in faeces for up to 2 

weeks before the onset of illness and for at least 1 week afterwards. 1 

In young children, HAV usually causes either an asymptomatic infection or a 

very mild illness without jaundice; adults are more likely to have symptomatic 

infection (over 70%). 2 Patients with symptomatic illness typically have a 4- to 

10-day prodrome of systemic (fever, malaise, weakness and anorexia) and 

gastrointestinal (nausea and vomiting) symptoms. Dark urine is usually the first 

specific manifestation of acute hepatitis A infection, followed a day or two later 

by jaundice and pale faeces. 2 The prodromal symptoms tend to wane with the 

onset of jaundice, although the anorexia and malaise may persist; pruritus and 

localised hepatic discomfort or pain may follow. 1 The duration of illness varies, 

but most patients feel better and have normal, or near normal, liver function 

tests within a month of the onset of illness. 3 Complications of hepatitis A are 

uncommon but include, on rare occasions, fulminant hepatitis. 4 The case-fatality 

rate of hepatitis A increases with age. 2 Hepatitis A does not cause chronic liver 

disease. Relapse has been found in up to 10% of cases, but recovery is universal. 

HAV does not cause chronic infection and immunity after infection is life-long. 2 

Diagnosis of hepatitis A is made by detecting anti-HAV IgM in serum during the 

acute illness. Anti-HAV IgM is invariably present by the time the patient presents 

and persists for 3 to 6 months after the acute illness. 1 Serum anti-HAV IgG alone 

indicates past infection (or possibly immunisation) and therefore immunity; it 

probably persists for life. 1 


Hepatitis A was a considerable public health problem in Australia in the 1990s. 

During this time, numerous outbreaks occurred in child day-care centres and 

preschools, 5 Indigenous communities, 6 communities of men who have sex with 

men, 7 schools and residential facilities for the disabled, 8 and communities of 

persons who inject drugs. 7 A very large outbreak of hepatitis A, associated with 

the consumption of raw oysters, occurred in New South Wales in 1997 and there 

was a large outbreak associated with semidried tomatoes during 2009. 9,10 


In recent years, hepatitis A notifications and hospitalisations have been low with 

a downward trend. 11 This has been accompanied by an increasing proportion of 

cases related to travel to countries where hepatitis A is endemic. 12-14 Advocacy 

for hepatitis A vaccination of travellers and those at increased risk because of 

lifestyle or occupation remains a priority, as does the hepatitis A vaccination 

program for Aboriginal and Torres Strait Islander children. Established 

initially in north Queensland in 1999 for Indigenous children aged 18 months, 6 

the hepatitis A vaccination program was expanded in 2005 to include all 

Indigenous children aged ≤2 years in the Northern Territory, Queensland, South 

Australia and Western Australia, contributing substantially to the decline in 

notifications. 15,16 In north Queensland, most Indigenous children >2 years of 

age have now been immunised against hepatitis A. However, it is important to 

note that Indigenous children remain at considerably greater risk – not only of 

acquiring hepatitis A, but also for being hospitalised with the infection – than 

non-Indigenous children. 11,17 This is particularly true for Indigenous children 

residing in other regions of Queensland, the Northern Territory, South Australia 

and Western Australia. (See also 3.1 Vaccination for Aboriginal and Torres Strait 

Islander people.) 


Monovalent hepatitis A vaccines 

• Avaxim – Sanofi Pasteur Pty Ltd (formaldehyde-inactivated hepatitis 

A virus [GBM strain]). Each 0.5 mL pre-filled syringe contains 160 

antigen units of hepatitis A virus (HAV) antigens inactivated by 

formaldehyde; 0.3 mg aluminium as aluminium hydroxide; 2.5 µL 

phenoxyethanol; 12.5 µg formaldehyde; traces of neomycin and 

bovine serum albumin. 

• Havrix Junior – GlaxoSmithKline (formaldehyde-inactivated 

hepatitis A virus [HM175 strain]). Each 0.5 mL monodose vial or 

pre-filled syringe contains 720 ELISA units of HAV antigens; 0.25 mg 

aluminium as aluminium hydroxide; traces of formaldehyde, 

neomycin and polysorbate 20. 

• Havrix 1440 – GlaxoSmithKline (formaldehyde-inactivated 

hepatitis A virus [HM175 strain]). Each 1.0 mL monodose vial or 

pre-filled syringe contains 1440 ELISA units of HAV antigens; 0.5 

mg aluminium as aluminium hydroxide; traces of formaldehyde, 

neomycin and polysorbate 20. 


4.4 HEPATITIS A

• Vaqta Paediatric/Adolescent formulation – CSL Limited/Merck & Co 

Inc (formaldehyde-inactivated hepatitis A virus [CR326F strain]). Each 

0.5 mL monodose vial or pre-filled syringe contains approximately 

25 units (U) of hepatitis A virus protein; 0.225 mg aluminium as 

aluminium hydroxide; 35 µg borax; traces of formaldehyde, neomycin 

and bovine serum albumin. 

• Vaqta Adult formulation – CSL Limited/Merck & Co Inc 

(formaldehyde-inactivated hepatitis A virus [CR326F strain]). Each 

1.0 mL monodose vial or pre-filled syringe contains approximately 

50 U of hepatitis A virus protein; 0.45 mg aluminium as aluminium 

hydroxide; 70 µg borax; traces of formaldehyde, neomycin and bovine 

serum albumin. 

Combination vaccines that contain hepatitis A 

• Twinrix Junior (360/10) – GlaxoSmithKline (formaldehyde-inactivated 

hepatitis A virus [HM175 strain] and recombinant hepatitis B vaccine). 

Each 0.5 mL monodose vial or pre-filled syringe contains 360 ELISA 

units of HAV antigens, 10 µg recombinant DNA hepatitis B surface 

antigen protein; 0.225 mg aluminium as aluminium phosphate/ 

hydroxide; traces of formaldehyde, neomycin, trometamol and 

polysorbate 20. May contain yeast proteins. 

• Twinrix (720/20) – GlaxoSmithKline (formaldehyde-inactivated 







• Vivaxim – Sanofi Pasteur Pty Ltd (formaldehyde-inactivated hepatitis A 

virus [GBM strain] and typhoid Vi capsular polysaccharide). Supplied 

in a dual-chamber syringe which enables the two vaccines to be mixed 

just before administration. Each 1.0 mL dose of mixed vaccine contains 

160 ELISA units of inactivated hepatitis A virus antigens, 25 µg purified 

typhoid Vi capsular polysaccharide strain Ty2; 0.3 mg aluminium as 

aluminium hydroxide; 2.5 µL phenoxyethanol; 12.5 µg formaldehyde; 

traces of neomycin, bovine serum albumin and polysorbate 80. 


Inactivated hepatitis A vaccines are prepared from HAV harvested from 

human diploid cell cultures, which are then purified by ultrafiltration and 

chromatography, inactivated by formaldehyde, and adsorbed onto aluminium 

hydroxide adjuvant. Although the vaccines are prepared from differing strains of 

HAV, there is only one known serotype; immunity induced by a particular strain 

probably provides protection against all strains. 1 

Inactivated hepatitis A vaccines induce HAV antibodies (anti-HAV) at titres 

many-fold greater than are provided by the recommended dose of normal 

human immunoglobulin. Although the vaccines are highly immunogenic (see 

below), antibody titres are usually below the detection limits of the routinely 

available commercial tests for anti-HAV. 1 Therefore, serological testing to assess 

immunity after vaccination against hepatitis A is neither necessary nor appropriate. 

Likewise, it is also inappropriate to undertake testing if an individual cannot 

recall if he/she has been vaccinated against hepatitis A in the past; if no 

vaccination records are available, vaccination should be advised. However, 

certain groups of people should be screened for natural immunity to hepatitis A 

to avoid unnecessary vaccination: those born before 1950; those who spent their 

early childhood in endemic areas; and those with an unexplained previous 

episode of hepatitis or jaundice. In addition, it is necessary to test for other causes 

of hepatitis, in particular hepatitis B, in those with unexplained jaundice. 

Hepatitis A vaccines are highly immunogenic in both children and adults, 

with virtually universal seroconversion 4 weeks after vaccination. 1,18,19 Two 

randomised clinical trials conducted in the early 1990s showed that the 

vaccines have a very high protective efficacy, approaching 100%. 20,21 This 

finding is supported by the apparent eradication of hepatitis A from Indigenous 

communities in north Queensland and the Northern Territory since the 

introduction of the vaccination program in those regions. 6,16 

The duration of immunity, and therefore protection, following vaccination is 

not certain. However, vaccine-induced anti-HAV probably persists for many 

years. There is no current evidence that booster doses are required; in healthy 

individuals, it is quite possible that they will never be required. 22 


Transport according to National vaccine storage guidelines: Strive for 5. 23 

Store at +2°C to +8°C. Do not freeze. 


Inactivated hepatitis A vaccines are to be given by IM injection. 

The recommended doses and schedules are shown in Table 4.4.1. 


4.4 HEPATITIS A

Table 4.4.1: Recommended doses and schedules for use of inactivated hepatitis 

A and hepatitis A combination vaccines* 

Vaccine 

Age of 

vaccine 

recipient 

(years) 

Dose 

(HAV 

antigen) 

Monovalent hepatitis A vaccines 

Volume 

per dose 

(mL) 

Number 

of doses 


Vaccination 

schedule 

Avaxim ≥2 160 ELISA U 0.5 2 1st dose: day 0 (day of vaccination) 

2nd dose: 6 to 12 months after 1st dose 

Havrix 

Junior 

Havrix 

1440 

Vaqta 

Paediatric/ 

Adolescent 

Vaqta 

Adult 

2–


Hepatitis A vaccines are inactivated vaccines and can be administered either 

simultaneously with, or at any time before or after, all other vaccines relevant 

to international travel. 24 

Combination hepatitis A/hepatitis B vaccines can be administered 


to international travel. 

The combination hepatitis A/typhoid vaccine can be administered 


to international travel. 

Interchangeability of hepatitis A vaccines 

Although the manufacturers use slightly different production methods and 

quantify the HAV antigen content in their respective vaccines differently, the 

hepatitis A vaccines of the different manufacturers used in ‘equivalent’ schedules 

in Table 4.4.1 can be considered interchangeable, when given in a 2-dose course. 

As there is only one brand of combination hepatitis A/hepatitis B vaccine, 

interchangeability is not relevant. (See also ‘Recommendations for the use of 

combination hepatitis A/hepatitis B vaccines’ in 4.4.7 Recommendations below.) 


Hepatitis A vaccination is recommended for persons with an increased risk 

of acquiring hepatitis A and/or who are at increased risk of severe disease. 

Serological testing for immunity to hepatitis A from previous infection is 

not usually required prior to vaccination, but may be indicated in some 

circumstances (see ‘Serological testing for hepatitis A immunity from infection 

and/or vaccination’ below). 

When vaccination against both hepatitis A and hepatitis B (or hepatitis A and 

typhoid) is indicated, combination vaccines may be used, as described below. 

Recommendations for hepatitis A vaccine 

Hepatitis A vaccination is recommended for the following groups: 

Aboriginal and Torres Strait Islander children residing in the Northern Territory, Queensland, 

South Australia and Western Australia 

Two doses of hepatitis A vaccine are required for Aboriginal and Torres Strait 

Islander children living in these jurisdictions, due to the increased risk for 

hepatitis A in this population (see 4.4.3 Epidemiology above). Vaccination for 

these children should commence in the 2nd year of life, with the 1st dose given 

between 12 and 18 months of age, and the 2nd dose given between 18 and 24 

months of age. The recommended interval between doses is 6 months (see 

Table 4.4.1). State/territory health authorities should be contacted about local 

hepatitis A vaccination schedules, including catch-up. 


4.4 HEPATITIS A

Travellers (≥1 year of age) to hepatitis A endemic areas 

Travellers to (≥1 year of age), and expatriates living in, moderately to highly 

endemic areas for hepatitis A should receive hepatitis A vaccine. 25 A single dose 

of a monovalent hepatitis A vaccine provides protective levels of anti-HAV for at 

least a year; 1 a 2nd dose is recommended 6 to 12 months following the 1st dose, 

to increase the duration of protection (see Table 4.4.1). 

Persons whose occupation puts them at increased risk of acquiring hepatitis A 

Persons whose occupation puts them at increased risk of acquiring hepatitis A 

include: persons who live or work in rural and remote Indigenous communities 

and/or persons who regularly provide care for Aboriginal and Torres Strait 

Islander children in the Northern Territory, Queensland, South Australia and 

Western Australia; staff working in early childhood education and care; carers 

of persons with developmental disabilities; and plumbers or sewage workers. 

See also 3.3 Groups with special vaccination requirements, Table 3.3.7 Recommended 

vaccinations for persons at increased risk of certain occupationally acquired vaccinepreventable 

diseases. 

Persons whose lifestyle puts them at increased risk of acquiring hepatitis A 

Persons who engage in anal intercourse, men who have sex with men, persons 

who inject drugs (including inmates of correctional facilities) and sex industry 

workers are at increased risk of acquiring hepatitis A. 26 See also 3.3 Groups with 

special vaccination requirements. 

Persons with developmental disabilities 

Vaccination is recommended for persons with developmental disabilities, and 

susceptible carers, who attend both residential and non-residential facilities for 

persons with developmental disabilities. Although conditions/measures to limit 

the likelihood of hepatitis A transmission in such facilities have improved in 

recent decades, outbreaks of hepatitis A can occur in these settings. 26 

Persons with chronic liver disease, liver solid organ transplant recipients and/or those chronically 

infected with either hepatitis B or hepatitis C viruses 

Hepatitis A vaccination is recommended for persons with chronic liver disease 

of any aetiology. 2,26 Those with chronic liver disease of mild to moderate severity 

mount a satisfactory immune response following vaccination, but those with 

end-stage liver disease do not respond as well, and liver transplant recipients 

may not respond at all. 27,28 Nevertheless, all those with chronic liver disease who 

are non-immune to hepatitis A should be vaccinated, preferably as early in the 

course of the disease as possible. 

Vaccination is recommended for persons with chronic hepatitis C and hepatitis B 

infection because of the high case-fatality rate among these persons if they 

acquire hepatitis A. 2 


Recommendations for the use of combination hepatitis A/hepatitis B vaccines 

Combination hepatitis A/hepatitis B vaccines should be considered for 

susceptible persons in whom both hepatitis A and hepatitis B vaccines are 

recommended. Vaccination is usually provided in a 3-dose schedule (see Table 

4.4.1). Twinrix (720/20) can be administered in a 2-dose regimen in persons 1 to 

fever. This combination is particularly useful for those already immunised 

against hepatitis B. 

To provide longer-term protection against hepatitis A, a single dose of a 

monovalent adult formulation hepatitis A vaccine administered between 6 and 

36 months after the single dose of combination hepatitis A/typhoid vaccine 

is required (see Table 4.4.1). If there is a continued risk of typhoid infection, a 

booster dose of parenteral typhoid Vi polysaccharide vaccine is required 

3 years after the single dose of combination hepatitis A/typhoid vaccine. The 

combination hepatitis A/typhoid vaccine may be used as a ‘booster’ vaccine 

for hepatitis A if a person received a previous dose of a monovalent adult 

formulation hepatitis A vaccine; this should be given at a minimum interval of 

6 months after the 1st dose of hepatitis A vaccine. 

Serological testing for hepatitis A immunity from infection and/or vaccination 

Serological testing for immunity to hepatitis A is not recommended before 

routine administration of hepatitis A vaccine to those in most of the categories 

above, for example, Aboriginal and Torres Strait Islander children or travellers. 

However, previous infection with hepatitis A is more likely to have occurred in 

persons born before 1950, those who spent their early childhood in an endemic 

area, and those with an unexplained previous episode of hepatitis or jaundice. 

In such persons, testing for total hepatitis A antibodies or anti-HAV IgG may be 

indicated, and, if positive, indicates immunity to hepatitis A. Such persons do not 

need hepatitis A vaccination. 




Serological testing following vaccination is not routinely required. 


Hepatitis A vaccine is not routinely recommended for pregnant or breastfeeding 

women, but can be given where vaccination is considered necessary (see 4.4.7 

Recommendations above). 




The only absolute contraindications to hepatitis A vaccines are: 

• anaphylaxis following a previous dose of any hepatitis A vaccine 


Combination vaccines containing the hepatitis B component are contraindicated 

in persons with a history of anaphylaxis to yeast. 



The most common adverse events following administration of hepatitis A 

vaccines are mild local events of a short duration, probably caused by the 

aluminium hydroxide adjuvant. About 15% of adults report headache and 

approximately 5% report malaise or fatigue following vaccination. 26 Up to 20% of 

children who receive either Havrix or Vaqta experience soreness at the injection 

site. In both adults and children, systemic adverse events such as headache and 

fever are much less common than local adverse events. 26 

Hepatitis A vaccines do not affect liver enzyme levels. They can be safely given 

to persons with HIV infection, and do not adversely affect either the HIV load or 

CD4 + cell count. 30 

4.4.11 Public health management of hepatitis A 

Hepatitis A is a notifiable disease in all states and territories in Australia. Detailed 

information regarding the management of hepatitis A cases and contacts can be 

found in the national guidelines for control of hepatitis A31 (www.health.gov.au/ 

cdnasongs). 

Further instructions can also be obtained from state/territory public health 

authorities (see Appendix 1 Contact details for Australian, state and territory 


Post-exposure prophylaxis using hepatitis A vaccine or normal human 

immunoglobulin (NHIG) can be used to prevent secondary cases in close 

contacts of hepatitis A cases. However, vaccination is recommended in preference 

to NHIG for use in post-exposure prophylaxis in persons ≥12 months of age who 

are immunocompetent (see Part 5 Passive immunisation). 31 


None. 

References 




4.4 HEPATITIS A

4.5 HEPATITIS B 


Hepatitis B virus (HBV) contains circular, partially double-stranded DNA. The 

outer surface of the virus is glycolipid, which contains the hepatitis B surface 

antigen (HBsAg). Other important antigenic components are the hepatitis B core 

antigen (HBcAg) and hepatitis B e antigen (HBeAg). HBcAg is not detectable 

in serum, but can be detected in liver tissue in persons with acute or chronic 

hepatitis B infection. HBeAg, and antibodies against HBeAg (anti-HBe) or the 

HBcAg (anti-HBc), are serological markers of HBV infection. Antibodies against 

HBsAg (anti-HBs) indicate immunity, which may result from either natural 

infection or immunisation (in which case there would not be any markers of HBV 

infection). Persistence of HBsAg denotes infectivity, which is greater if HBeAg 

and/or HBV DNA are also positive. 1 Occult hepatitis B infection is characterised 

by the presence of HBV DNA in the liver (with or without detectable HBV DNA 

in the serum) and negative HBsAg. 2 


In approximately 30 to 50% of adults, infection causes symptomatic acute 

hepatitis, but in neonates and young children, particularly those


The prevalence of chronic HBV infection differs in different parts of the world, 

and may be quite variable within countries. The prevalence of chronic HBV 

infection varies from less than 0.5% among Caucasians in the United States, 

northern Europe and Australia, 1 to 5% in the Mediterranean countries, parts 

of eastern Europe, Africa, Central and South America, up to greater than 10% 

in many sub-Saharan African, East and Southeast Asian and Pacific island 

populations. 7-10 In regions of moderate to high prevalence of HBsAg (where ≥2% 

of the population is HBsAg-positive), infections are mainly acquired perinatally 

or in early childhood. 1 

Chronic infection and its sequelae, including cirrhosis and hepatocellular 

carcinoma, contribute to the majority of HBV disease burden in Australia. In 

recent decades, the burden from such disease has been increasing, concurrent 

with the increasing number of immigrants from regions of high HBV 

prevalence. 11 Aboriginal and Torres Strait Islander people, and migrants born 

in Asia and Pacific islands, North Africa, Middle Eastern and Mediterranean 

countries, have a significantly increased prevalence of chronic HBV infection 

compared with the rest of the Australian-born population. 12,13 First-generation 

immigrants of culturally and linguistically diverse background, who are 

mostly from countries of high HBV endemicity, usually retain the prevalence 

of chronic HBV infection of their country of origin. Other population groups 

with an increased prevalence of markers of HBV infection include patients with 

HIV infection, persons who used injected drugs between 1980 and 1990, and 

household contacts of someone diagnosed with hepatitis between 1980 and 

1990. 13 Notification of chronic HBV infection depends on levels of hepatitis B 

testing and reporting, and a substantial proportion of persons with chronic HBV 

infection remain undiagnosed. It has been estimated by mathematical modelling 

that, in 2010, about 170 000 people were living with HBV infection in Australia, 

with about 335 deaths due to HBV infection in that year. 14 

Newly acquired cases of HBV infection in Australia mostly occur in young 

adults, through injecting drug use, skin penetration procedures or sexual 

contact. 15 Between 2006 and 2010, the notification rate of newly acquired 

hepatitis B in Australia ranged from 1.0 to 1.4 per 100 000 population. 

Since 2001, the rate of diagnosis of newly acquired infections has declined 

substantially among people aged 15–29 years and has remained relatively stable 

among people aged ≥30 years. 14-16 However, some new HBV infections are 

asymptomatic and may go undetected. 

Similar to chronic infection, higher rates of notified cases of newly acquired 

hepatitis B, or hospitalisation due to acute hepatitis B, have been reported 

among Aboriginal and Torres Strait Islander people compared with the general 

Australian population. 17,18 In one United States study, adults with diabetes 

mellitus had a greater chance of developing acute hepatitis B disease than 


4.5 HEPATITIS B

the general population; 19 however, there are no published Australian studies 

examining this. 

Transmission of HBV may result from inoculation through broken or penetrated 

skin, or by mucosal contact with blood or other body fluids (mainly vaginal 

fluids and semen) from an infectious person. There are four major routes of 

HBV transmission: 

• perinatal transmission from infected mother to neonate (vertical 

transmission), usually occurring at or around the time of birth 

• parenteral or mucosal exposure to infected blood and other bodily fluids; 

common scenarios include: 

» sharing of contaminated equipment that penetrates the skin, such as 

needles (among persons who inject drugs), tattoo equipment, bodypiercing 

equipment, acupuncture equipment and razor blades 

» needle-stick injury, for example, in a healthcare setting 

» contact between infective body fluids and mucous membranes 

• sexual contact (including vaginal or anal intercourse, although the latter is 

associated with a higher risk) 

• non-sexual contact with an infected person (horizontal transmission), 

including household transmission, for example, child-to-child transmission 

through contact between open sores or wounds. 

In Australia, screening of blood and organ donors using nucleic acid 

amplification testing has virtually eliminated the risk of transmission of 

hepatitis B through blood transfusion and organ transplants. 20,21 Saliva may 

contain levels of virus that are likely to be infective only if inoculated directly 

into tissue (ocular or mucous membranes). The risk of transmission by 

inadvertent inoculation by other means, such as by toothbrush, razor etc., or 

through close personal contact in households in which one or more infected 

persons reside, is low but not negligible. 22-29 

The strategy for prevention of hepatitis B through immunisation in Australia 

commenced in the early 1980s, with vaccination programs targeting individuals 

with increased risk of HBV exposure, including infants at particular 

risk of infection at birth. Universal infant vaccination commenced in the 

Northern Territory in 1990. A universal hepatitis B vaccination program was 

recommended for infants and adolescents in 1996. The adolescent program 

commenced in some states and territories in 1997 and the universal infant 

program, which includes a dose given at birth, began nationally in 2000. The 

adolescent program will continue until those immunised for hepatitis B in the 

infant program reach adolescence. 



Monovalent hepatitis B vaccines 

• Engerix-B – GlaxoSmithKline (recombinant DNA hepatitis B vaccine). 

Adult formulation – Each 1.0 mL monodose vial or pre-filled syringe 

contains 20 µg recombinant hepatitis B surface antigen (HBsAg) 

protein, adsorbed onto 0.5 mg aluminium as aluminium hydroxide. 

Paediatric formulation – Each 0.5 mL monodose vial or pre-filled 

syringe contains 10 µg HBsAg protein, adsorbed onto 0.25 mg 

aluminium as aluminium hydroxide. 

Both formulations may contain yeast proteins. 

• H-B-Vax II – CSL Limited/Merck & Co Inc (recombinant DNA 

hepatitis B vaccine). Adult formulation – Each 1.0 mL monodose 

vial or pre-filled syringe contains 10 µg recombinant HBsAg protein, 

adsorbed onto 0.5 mg aluminium hydroxide. Paediatric formulation 

– Each 0.5 mL monodose vial or pre-filled syringe contains 5 µg 

recombinant HBsAg protein, adsorbed onto 0.25 mg aluminium 

hydroxide. Dialysis formulation – Each 1.0 mL monodose vial 

contains 40 µg recombinant HBsAg protein, adsorbed onto 0.5 mg 

aluminium hydroxide. 

All formulations may contain yeast proteins. 

Combination vaccines that contain hepatitis B 

• Infanrix hexa – GlaxoSmithKline (DTPa-hepB-IPV-Hib; diphtheriatetanus-acellular 

pertussis-hepatitis B-inactivated poliovirus- 

Haemophilus influenzae type b). The vaccine consists of both a 0.5 mL 

pre-filled syringe containing ≥30 IU diphtheria toxoid, ≥40 IU tetanus 

toxoid, 25 µg pertussis toxoid, 25 µg filamentous haemagglutinin, 8 µg 

pertactin, 10 µg recombinant HBsAg, 40 D-antigen units inactivated 




polysorbate 20, polymyxin and neomycin; and a vial containing a 

lyophilised pellet of 10 µg purified Hib capsular polysaccharide (PRP) 

conjugated to 20–40 µg tetanus toxoid. May contain yeast proteins. 

• Twinrix Junior (360/10) – GlaxoSmithKline (formaldehyde-inactivated 






4.5 HEPATITIS B



• Twinrix (720/20) – GlaxoSmithKline (formaldehyde-inactivated 







Hepatitis B vaccines are prepared using recombinant technology. After 

purification, the HBsAg protein is adsorbed onto elemental aluminium (as 

hydroxide and/or phosphate). Hepatitis B vaccines may contain up to 1% yeast 

proteins (but no yeast DNA). 

The Engerix-B and the H-B-Vax II vaccines are manufactured by different 

processes, and the HBsAg content of an ‘equivalent’ dose of these 2 vaccines is 

different. Studies of hepatitis B vaccines have been conducted using different 

schedules and intervals for different age groups. Acceptable schedules are shown 

in Table 4.5.1 and are described below. 

The standard 3-dose schedule and variations 

Neonates, children and young adults aged

For older children and young adults aged

of seroconversion increases progressively from approximately 35% after the 1st 

dose to more than 90% after the 3rd dose. There is evidence of immunity in most 

vaccine recipients after administration of 2 doses of a 3-dose schedule. However, 

the 3rd dose is necessary to increase the percentage of responders and to provide 

long-term protection. 

Alternative 2-dose schedule for adolescents 

Several studies have demonstrated that adolescents 11–15 years of age who 

receive 2 doses of adult formulation monovalent hepatitis B vaccine 4 to 

6 months apart develop similar protective antibody levels to those vaccinated 

using paediatric formulations in the standard 3-dose schedule. 41-43 

Using a 2-dose schedule for the 11–15 years age group may improve 

compliance and will provide comparable immunogenicity to that of a 3-dose 

paediatric schedule. Adolescents (11–15 years of age) can be vaccinated with 

the adult formulation of either H-B-Vax II or Engerix-B in a 2-dose schedule 

(see Table 4.5.1). 

Table 4.5.1: Recommended schedules for use of monovalent hepatitis B and 

hepatitis B combination vaccines 

Vaccine 

Age of 

vaccine 

recipient 

Recommended infant schedule 

Engerix-B (paediatric 

formulation) 

or 

H-B-Vax II (paediatric 

formulation) 

Combination hepatitis 

B-containing vaccine 

(e.g. Infanrix hexa 

(DTPa-hepB-IPV-Hib) 

birth 

2, 4 and 6 ‡ 

months 

Dose 

(HBsAg 

protein) 

10 µg 

(Engerix-B) 

or 

5 µg 

(H-B-Vax II) 

Volume per 

dose (mL) 

Number of 

doses 

0.5 1 

10 µg 0.5 3 

Monovalent hepatitis B vaccines – standard 3-dose schedule 

Engerix-B (paediatric 

formulation) 

Engerix-B (adult 

formulation) 

H-B-Vax II (paediatric 

formulation) 

Vaccine 

Age of 

vaccine 

recipient 

Dose 

(HBsAg 

protein) 

Volume per 

dose (mL) 

Number of 

doses 

Monovalent hepatitis B vaccines – standard 3-dose schedule 

H-B-Vax II (adult 

formulation) 

H-B-Vax II (dialysis 

formulation) 

≥20 years 10 µg 1.0 3 

≥20 years 40 µg 1.0 3 

Recommended schedule 

intervals* † 

1st dose: day 0 (day of 

vaccination) 

2nd dose: 1 month after 1st dose 

3rd dose: 6 months after 1st dose 

1st dose: day 0 (day of 

vaccination) 

2nd dose: 1 month after 1st dose 

3rd dose: 6 months after 1st dose 

Monovalent hepatitis B vaccines – 2-dose schedule ONLY for adolescents aged 11–15 years 

Engerix-B (adult 

formulation) 

H-B-Vax II (adult 

formulation) 

11–15 

years 

11–15 

years 

Combination hepatitis A/hepatitis B vaccines 

Twinrix (720/20) § 

Twinrix Junior 

(360/10) 

1–

months following commencement of the schedule. However, multiple studies 

have consistently shown that antibody levels are substantially lower at month 7, 

after 3 accelerated doses, than after the standard 3-dose schedule (0, 1, 6 months). 39 

Also, some studies, in particular among persons who inject drugs and/or inmates 

of correctional facilities, have shown a lower proportion of subjects attaining the 

seroprotective antibody level after 3 doses of an accelerated schedule than after 

the standard 3-dose schedule. 39,44,45 After the 4th dose of an accelerated schedule, 

administered at 12 months, anti-HBs antibody levels are higher or comparable 

to those after a standard 3-dose schedule. Hence, it is important for long-term 

protection that a 4th dose be administered at 12 months to complete an 

accelerated schedule. 

Accelerated schedules should only be used for those persons with an imminent 

risk of exposure, such as those intending to travel to hepatitis B endemic areas 

with a very limited time before departure. As higher seroprotective rates after the 

3rd dose of an accelerated 4-dose schedule are seen after the 0, 1, 2, 12 months 

schedule than after the 0, 7, 21 days, 12 months schedule, it is recommended that 

the latter schedule only be used in exceptional circumstances. 

Table 4.5.2: Accelerated hepatitis B vaccination schedules (for persons with 

imminent risk of exposure) 

Vaccine 

Engerix-B 

(paediatric 

formulation) 

Engerix-B 

(adult 

formulation) 

Twinrix 

(720/20) 

Age of 

vaccine 

recipient 

(years) 

Dose 

(HBsAg 

protein) 

Volume 

(mL) 

Number 

of doses 

Combination hepatitis A/hepatitis B vaccine schedules 

The schedules for combination hepatitis A/hepatitis B vaccines are shown in 

Table 4.5.1 (and 4.4 Hepatitis A). Three-dose schedules for adults and children 

aged

mixed regimens that used two monovalent hepatitis B vaccines from different 

manufacturers. 47 As there is only one brand of combination hepatitis A/ 

hepatitis B vaccine, interchangeability is not relevant. (See also ‘Combination 

hepatitis A/hepatitis B vaccine schedules’ in 4.5.4 Vaccines above.) 


Infants and young children 

The recommended hepatitis B vaccine schedule for infants from birth is shown in 

Table 4.5.1. A birth dose of monovalent paediatric formulation hepatitis B vaccine 

is recommended for all newborn infants. Following this birth dose, 3 doses of a 

hepatitis-B-containing combination vaccine (usually provided as DTPa-hepB- 

IPV-Hib) are recommended for all children, at 2, 4 and 6 months of age. Thus, a 

total of 4 doses of hepatitis B vaccine are provided in the 1st year of life. The 1st 

dose of a hepatitis B-containing combination vaccine can be given as early as 

6 weeks of age. If the 1st dose is given at 6 weeks of age, the next scheduled 

doses should still be given at 4 months and 6 months of age. 

If an infant has not received a birth dose within the 1st 7 days of life, a primary 

3-dose course of a hepatitis B-containing combination vaccine should be given, at 

2, 4 and 6 months of age; catch-up of the birth dose is not necessary. Irrespective 

of whether a birth dose was given, the infant should not be given the final dose 

before 24 weeks of age. 

The rationale for recommending the birth dose for all newborn infants is not only 

to prevent vertical transmission from a mother with chronic hepatitis B infection 

(recognising that there may be errors or delays in maternal testing, reporting, 

communication or appropriate response), but also to prevent horizontal 

transmission to the infant in the first months of life from persons with chronic 

hepatitis B infection who are household or other close contacts. 48 The birth dose 

should be given as soon as the baby is medically stable, and preferably within 

24 hours of birth. Every effort should be made to administer the vaccine before 

discharge from the obstetric hospital or delivery unit. All newborns of mothers 

known to have chronic hepatitis B infection must be given a birth dose of 

hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) (see ‘Management of 

infants born to mothers who are HBsAg-positive’ below). 

Although it is not routinely recommended in Australia, infants or toddlers 

who have received a 3-dose schedule of monovalent vaccine (often given 

overseas) with doses at birth, 1–2 months of age and ≥6 months of age can also 

be considered fully vaccinated. The important consideration is that there should 

have been an interval of at least 2 months between the 2nd and 3rd doses, and 

that the final dose should not be administered before 24 weeks of age (see also 

4.5.4 Vaccines above). 


Management of infants born to mothers who are HBsAg-positive 

Routine antenatal screening of pregnant women for HBsAg is recommended 

to enable appropriate management to prevent newborn infants developing 

HBV infection (see 4.5.2 Clinical features and 4.5.3 Epidemiology above). 49-51 It also 

enables appropriate follow-up and management of mothers who have chronic 

HBV infection, identification of the HBV immune status of other household 

members, and protection of those who are susceptible to HBV infection. 

Infants born to HBsAg-positive mothers should be given HBIG and a dose of 

monovalent hepatitis B vaccine on the day of birth, concurrently but in separate 

thighs. The dose of HBIG is 100 IU, to be given by IM injection. It is preferable to 

administer HBIG immediately after birth (preferably within 12 hours of birth and 

certainly within 48 hours) as its efficacy decreases markedly if given more than 

48 hours after birth. 

The dose of monovalent hepatitis B vaccine should be given to the infant 

preferably within 24 hours of birth, and definitely within 7 days. This regimen 

results in seroconversion rates of more than 90% in neonates, even with 

concurrent administration of HBIG. Vaccination should not be delayed beyond 

7 days after birth, as vaccination alone has been shown to be reasonably effective 

in preventing infection, provided it is given early. 52 Three subsequent doses of 

a hepatitis B-containing vaccine should be given, at 2, 4 and 6 months of age, so 

that the infant receives a total of 4 doses of hepatitis B-containing vaccines. 

Anti-HBs antibody and HBsAg levels should be measured in infants born to 

mothers with chronic hepatitis B infection 3 to 12 months after completing 

the primary vaccine course. Testing should not be performed before 9 months 

of age to avoid detection of anti-HBs antibodies from HBIG given at birth. If 

anti-HBs antibody levels are adequate (≥10 mIU/mL) and HBsAg is negative, 

then the infant is considered to be protected30 (see ‘Serological testing following 

hepatitis B vaccination’ below). If the anti-HBs level is

HIV-positive and immunocompromised children 

All HIV-positive and immunocompromised children should be age-appropriately 

vaccinated against hepatitis B. 

HIV-positive children should receive 3 doses of hepatitis B vaccine using an 

adult formulation (i.e. double the standard recommended dose for children). In a 

limited number of studies, paediatric haemodialysis patients have demonstrated 

improved response when given higher doses in a 3-dose schedule. 56,57 

For specific hepatitis B recommendations for immunocompromised children, see 

3.3.3 Vaccination of immunocompromised persons. 

Adolescents 

Vaccination of adolescents 10–13 years of age is recommended for all those in 

this age group who have not already received a primary course of hepatitis B 

vaccine. Refer to your state/territory health authority for further information 

about hepatitis B vaccine for this age group (see Appendix 1 Contact details for 

Australian, state and territory government health authorities and communicable disease 

control). 

As the risk in Australian schools is very low, 58 vaccination of classroom contacts 

of hepatitis B cases is seldom indicated. Nevertheless, vaccination of all children 

and adolescents should be encouraged. 

A 2-dose schedule of hepatitis B vaccine using the adult formulation of either of 

the available monovalent vaccines should be considered for adolescents aged 

11–15 years who are to receive hepatitis B vaccination (see Table 4.5.1 and 4.5.4 

Vaccines above). A 2-dose schedule increases compliance and thus protection in 

this age group. 

Adolescents who did not receive an age-appropriate completed course of 

vaccination should be identified and offered catch-up vaccination, particularly if 

they fall into one of the risk categories for hepatitis B infection, discussed under 

‘Adults’ below. 

Adults 

Hepatitis B vaccination is recommended for the following groups of adults 

because they are either at a higher risk of acquiring hepatitis B infection and/ 

or at higher risk of severe disease. Serological testing for previous or chronic 

hepatitis B infection may be indicated in many circumstances (see ‘Serological 

testing prior to hepatitis B vaccination’ below). See also 3.3 Groups with special 

vaccination requirements. 

When vaccination against both hepatitis B and hepatitis A is indicated, the 

combination hepatitis A/hepatitis B vaccines may be used. See Tables 4.5.1 and 

4.5.2 above and ‘Recommendations for the use of combination hepatitis A/ 

hepatitis B vaccines’ below. 


Household or other close (household-like) contacts of persons with hepatitis B 

There is a low, but definite, risk of transmission from a person with acute or 

chronic hepatitis B to household or other close residential contacts (e.g. students 

or asylum seekers sharing residential facilities). This can be reduced by avoiding 

contact with blood or other body fluids and not sharing items that may penetrate 

the skin (such as combs, nail brushes, toothbrushes and razors). Immunisation 

of susceptible household-like contacts is strongly recommended. This includes 

household members of the adoptive family if the adopted child is known to have 

chronic hepatitis B infection. 

Sexual contacts of persons with hepatitis B 

Susceptible sexual partners of persons with acute hepatitis B should be offered 

post-exposure HBIG and hepatitis B vaccination; both should be initiated within 

14 days of the last sexual contact (see 4.5.11 Public health management of hepatitis B 

below and Table 4.5.3). Susceptible partners of those with chronic HBV infection 

should also be offered vaccination. 

Hepatitis B is relatively common in clients of sexual health services and 

vaccination should be offered to susceptible persons at the time of first 

attendance. 

Susceptible, sexually active men who have sex with men should be vaccinated. 

The combination hepatitis A/hepatitis B vaccine may be appropriate for men 

who have sex with men, if they are not immune to either disease, as they are 

at increased risk of both conditions (see ‘Recommendations for the use of 

combination hepatitis A/hepatitis B vaccines’ below). 

Migrants from hepatitis B endemic countries 

Migrants from hepatitis B endemic countries have a higher likelihood of having 

been previously infected with hepatitis B and of having a close household contact 

with chronic hepatitis B infection. Such persons should be offered testing for 

hepatitis B, and vaccination if appropriate. (See also 3.3.8 Vaccination of migrants 

to Australia.) Areas of high endemicity, indicated by high seroprevalence of 

HBsAg, include most of East and Southeast Asia (except Japan), Pacific island 

groups, parts of central Asia and the Middle East, the Amazon Basin, and sub- 

Saharan Africa. 59 

Aboriginal and Torres Strait Islander people 

There is an increased risk of acquiring new HBV infection among Aboriginal 

and Torres Strait Islander people compared with other Australians. 17,18 Although 

many younger Aboriginal and Torres Strait Islander people, especially children 

and adolescents, would have been eligible for, and have received, hepatitis B 

vaccination through population-wide vaccination programs, it is recommended 

that Aboriginal and Torres Strait Islander people have their risks and vaccination 

status for hepatitis B reviewed, be offered testing for previous hepatitis B 

infection, and be offered vaccination if non-immune. (See also 3.1 Vaccination for 

Aboriginal and Torres Strait Islander people.) 


4.5 HEPATITIS B

Adult haemodialysis patients and patients with severely impaired renal function in whom 

dialysis is anticipated 

Dialysis patients, and patients with severely impaired renal function in whom 

dialysis is anticipated, may be at increased risk of acquiring hepatitis B infection 

and also respond less well to vaccination. These patients should be given a larger 

than usual dose of hepatitis B vaccine. 

Adult haemodialysis or pre-dialysis patients should be given either: 

• 1.0 mL of Engerix-B adult formulation (20 µg) in each arm at each schedule 

point (i.e. effectively giving a double dose on each occasion) in a 4-dose 

schedule at 0, 1, 2 and 6 months; 60 or 

• a single dose of H-B-Vax II dialysis formulation (40 µg) on each occasion in a 

3-dose schedule at 0, 1 and 6 months. 

Solid organ and haematopoietic stem cell transplant recipients 

If seronegative for hepatitis B, solid organ transplant recipients should be 

vaccinated before transplantation as they may be at increased risk of infection 

from the transplanted organ. 61 Haematopoietic stem cell transplant recipients 

should be revaccinated following transplantation, due to the loss of immune 

memory that often follows the transplant procedure. (See also 3.3.3 Vaccination of 

immunocompromised persons.) 

HIV-positive adults and other immunocompromised adults 

HIV-positive adults, and other immunocompromised adults, may be at increased 

risk of acquiring hepatitis B infection and also respond less well to vaccination. 

Limited studies in HIV1-positive adults have demonstrated an improved and 

accelerated serological response to a schedule that consists of 4 double doses, 

comprising two injections of the standard adult dose (using Engerix-B) on each 

occasion, at times 0, 1, 2 and 6 months. 62,63 

Persons with chronic liver disease and/or hepatitis C 

Hepatitis B vaccination is recommended for those in this category who are 

seronegative for hepatitis B, because of the risk of severe liver disease following 

infection with hepatitis B. 64 

Persons who inject drugs 

Persons who inject drugs should be tested, and be vaccinated if they have not 

previously been infected with HBV. 

Recipients of certain blood products 

Screening of all blood donors for HBV using HBsAg and nucleic acid 

amplification tests has greatly decreased the incidence of transfusion-related 

hepatitis B virus infection. Since 2010, nucleic acid testing has been introduced 

nationally to improve detection of hepatitis B infection in donated blood, mainly 

through reduction of the infectious window period when acute hepatitis B 

infection may not be detected using HBsAg, but also through detecting persons 


with occult hepatitis B infection. This further reduces the residual risk of 

hepatitis B transmission through transfusion in Australia, from approximately 1 

in 739 000 to less than 1 in 1 million. 65 However, persons with clotting disorders 

who receive blood product concentrates, persons with recurrent transfusion 

requirements, and persons with underlying immunocompromise66 have an 

elevated risk of hepatitis B virus infection, and should therefore be vaccinated. 

Persons with developmental disabilities 

Vaccination is recommended for persons who attend either residential or nonresidential 

day-care facilities for persons with developmental disabilities. This 

is due to the high prevalence of markers indicating past or current infection in 

persons in these settings, including an HBsAg prevalence of >10%. 67-69 

Inmates of correctional facilities 

Inmates are at increased risk of hepatitis B infection because of the prevalence 

of chronic hepatitis B among inmates, and the potential for unprotected sexual 

intercourse, injecting drug use and amateur tattooing in correctional facilities. 

Therefore, they should be offered the opportunity to be screened for hepatitis B 

upon incarceration, as part of the preventive health program for blood-borne 

viruses, and vaccinated if susceptible. 

Sex industry workers 

Sex industry workers are one of the population groups at higher risk of HBV 

infection. They have been specifically identified as an important population on 

which to focus for the prevention of hepatitis B transmission. 70 They are at a 

particularly high risk if they engage in unprotected sex. 

Persons at occupational risk 

The risk to persons in certain occupations differs considerably from setting to 

setting in different parts of Australia. However, it is recommended that all staff 

directly involved in patient care and/or the handling of human blood or tissue 

should be vaccinated. In addition, standard precautions against exposure to 

blood or body fluids should be used as a matter of routine. 71 

Other occupations where the risk of acquiring hepatitis B is increased include: 

• police, members of the armed forces, emergency services staff and staff of 

correctional facilities; these persons should be vaccinated if they are assigned 

to duties that may involve exposure to blood/body fluids 

• funeral workers, embalmers and other workers who have regular contact 

with human tissue, blood or body fluids and/or used needles or syringes 

• staff involved in both residential and non-residential care of persons with 

developmental disabilities, due to the high prevalence of markers of past or 

current infection in persons in this setting67-69 • workers who perform skin penetration procedures (e.g. tattooists, bodypiercers). 


4.5 HEPATITIS B

Staff of child day-care centres will normally be at minimal risk of hepatitis B. If 

advice on risk is sought, the enquiry should be directed to the local public health 

authority. 

Contact sports generally carry a low risk of hepatitis B infection. However, ageappropriate 

hepatitis B vaccination is recommended. 

Travellers to hepatitis B endemic areas 

Persons travelling to regions of intermediate or high endemicity, either long-term 

or for frequent short terms, or who are likely to undertake activities that increase 

their risks of exposure to HBV during travel, should be vaccinated. 59 (See also 3.2 

Vaccination for international travel.) 

Recommendations for the use of combination hepatitis A/hepatitis B vaccines 

Combination hepatitis A/hepatitis B vaccines should be considered for 

susceptible persons in whom both hepatitis A and hepatitis B vaccines are 

recommended, including: 

• travellers to, and expatriates living in, moderately to highly endemic areas 

for hepatitis A and B 

• persons whose lifestyle puts them at increased risk of hepatitis A and 

hepatitis B (sexually active men who have sex with men, sex industry 

workers, persons who inject drugs and inmates of correctional facilities) 

• persons who attend or work at residential or non-residential facilities for 

people with developmental disabilities 

• persons with occupational risks of exposure to both hepatitis A and hepatitis B 

• persons with chronic liver disease and/or hepatitis C 

• solid organ transplant liver recipients or solid organ transplant recipients 

who have chronic liver disease (see Table 3.3.2 Recommendations for 

vaccinations for solid organ transplant (SOT) recipients). 

If a combination hepatitis A/hepatitis B vaccine is not available, monovalent 

hepatitis A and hepatitis B vaccines can be administered simultaneously (in 

separate syringes at separate sites) (see ‘Interchangeability of hepatitis B 

vaccines’ above). 

See 4.5.7 Recommendations above and 4.4 Hepatitis A for more details. See also 3.3 

Groups with special vaccination requirements. 

Booster doses 

Booster doses of hepatitis B vaccine (after completion of a primary course by a 

recommended schedule) are not recommended for immunocompetent persons. 

This applies to children and adults, including healthcare workers and dentists. 72-78 

This is because there is good evidence that a completed primary course of 

hepatitis B vaccination provides long-lasting protection. Even though vaccineinduced 

antibody levels may decline with time and may become undetectable, 


immune memory persists and is thought to result in a protective immune 

response on re-exposure. 79 However, booster doses are recommended for persons 

who are immunocompromised, in particular those with either HIV infection or 

renal failure. The time for boosting in such persons should be decided by regular 

monitoring of anti-HBs levels at 6- to 12-monthly intervals. 72 

Serological testing prior to hepatitis B vaccination 

Routine antenatal screening of all pregnant women for HBsAg is recommended 

to allow appropriate measures to be implemented to prevent newborn infants 

developing chronic HBV infection49-51 (see ‘Management of infants born to 

mothers who are HBsAg-positive’ above). 

Serological testing for evidence of past (or current) hepatitis B infection prior 

to vaccination may be warranted for certain older children, adolescents 

and adults. This is particularly so for those at increased risk of acquiring 

hepatitis B infection, such as persons who inject drugs, sex industry workers, 

immunocompromised persons, and those living in communities with higher 

prevalence of HBV, including migrant communities and Aboriginal and Torres 

Strait Islander people. Serological testing enables identification of persons who 

were infected by HBV, to facilitate timely appropriate clinical management and 

prevention of onward transmission, hence reducing population impact of HBV 

infection. Testing also identifies those who are susceptible to HBV infection and, 

as such, should be offered vaccination if they continue to have a high exposure 

risk (see 4.5.7 Recommendations above). 70 Testing for immunity to hepatitis A 

infection (and vaccination of susceptible at-risk persons with combination 

hepatitis A/hepatitis B vaccines) may also be indicated for some population 

groups at increased risk of hepatitis A exposure (see 4.4 Hepatitis A). 




Serological testing following hepatitis B vaccination 

Anti-HBs antibody and HBsAg levels should be measured in infants born to 

mothers with chronic hepatitis B infection 3 to 12 months after completing the 

primary vaccine course (for more information see ‘Management of infants born 

to mothers who are HBsAg-positive’ above). 

Other than for infants born to mothers with chronic hepatitis B infection, postvaccination 

serological testing is recommended 4 to 8 weeks after completion of 

the primary course for persons in the following categories: 

• those at significant occupational risk (e.g. healthcare workers whose work 

involves frequent exposure to blood and body fluids) 

• those at risk of severe or complicated HBV disease (e.g. persons who are 

immunocompromised, and persons with pre-existing liver disease not related 

to hepatitis B) 


4.5 HEPATITIS B

• those in whom a poor response to hepatitis B vaccination may occur (e.g. 

haemodialysis patients, persons with bleeding disorders vaccinated via the 

SC route) 

• sexual partners and household, or other close household-like, contacts of 

persons who are infected with hepatitis B. 30 

For these individuals, if adequate anti-HBs levels (≥10 mIU/mL) are not reached 

on serological testing 4 to 8 weeks after the 3rd dose, the possibility of HBV 

infection, including chronic HBV infection, should be investigated by testing for 

serological markers, including HBsAg and anti-HBc antibodies. In select cases 

in which hepatitis B infection is suspected, HBV nucleic acid testing may also be 

indicated, and expert advice regarding further management should be sought. 

If there are no markers of HBV infection, the individual should be managed 

as a non-responder to hepatitis B vaccination (see ‘Non-responders to primary 

vaccination’ below). 

If persons who are at significant risk of hepatitis B (such as healthcare workers) 

were not tested for anti-HBs within 4 to 8 weeks after completion of the 

documented primary course, they should still undergo serological testing to 

ensure immunity. If, on testing, they have an anti-HBs level of

to suggest that a higher proportion of subjects would respond with these higherdose 

regimens. 80-82 

For HBsAg-negative healthcare workers who are non-responders to a primary 

course of vaccination and to subsequent additional IM doses (≥5 doses in total), 

some small observational studies report that some individuals may respond 

to the vaccine administered intradermally. 83-85 Engerix-B (0.25 mL [5 μg] per 

dose) was used in these studies, giving up to 4 doses. 83 Younger age and longer 

duration (≥6 months) since the last IM dose may be associated with greater 

probability of response. 84 If an intradermal dose(s) is given, it is recommended 

that the anti-HBs levels be measured before each subsequent dose to assess for 

seroconversion. 

Persistent non-responders should be informed that they should be considered 

not protected against hepatitis B and should minimise exposures. They should 

also be informed about the need for HBIG within 72 hours of parenteral or 

mucosal exposure to HBV (see Table 4.5.3). 


Hepatitis B vaccine is not routinely recommended for pregnant or breastfeeding 

women. However, the WHO states that neither pregnancy nor breastfeeding is a 

contraindication to the use of this vaccine. 86 




The only absolute contraindications to hepatitis B vaccines are: 

• anaphylaxis following a previous dose of any hepatitis B vaccine 


In particular, hepatitis B vaccines are contraindicated in persons with a history of 

anaphylaxis to yeast. 


Extensive experience indicates that the birth dose of hepatitis B vaccine is 

very well tolerated by newborn infants. It does not interfere with either the 

establishment or maintenance of breastfeeding, and it is not associated with 

an increased risk of either fever, medical investigation for sepsis, or serious 

outcomes in newborns who were vaccinated compared with the unvaccinated. 87-89 

Adverse events after hepatitis B vaccination are transient and minor, and include 

soreness at the injection site (5%), fever (usually low grade; 2–3%), nausea, 

dizziness, malaise, myalgia and arthralgia. Fever can be expected in some 

neonates following immunisation with hepatitis B vaccine (0.6–3.7%). 

Anaphylaxis has been reported very rarely in adults, notably in yeast-sensitive 

individuals. 90 Although various adverse events such as demyelinating diseases, 


4.5 HEPATITIS B

Guillain-Barré syndrome and arthritis have been reported, there is no evidence of 

a causal relationship with hepatitis B vaccination. 90,91 

The World Health Organization Global Advisory Committee on Vaccine Safety 

states that ‘multiple studies and review panels have concluded that there is no 

link between MS [multiple sclerosis] and hepatitis B vaccination’. 92,93 

The vaccine produces neither therapeutic effects nor adverse events in persons 

with chronic HBV infection. It is also safe, though of no additional benefit, in 

those already immune to hepatitis B through past natural infection. 

4.5.11 Public health management of hepatitis B 

Acute hepatitis B and newly identified chronic hepatitis B are notifiable diseases 

in all states and territories in Australia. 

Further instructions about the public health management of hepatitis B, 

including management of cases of acute hepatitis B and newly identified chronic 

hepatitis B, and their contacts, should be obtained from state/territory public 

health authorities (see Appendix 1 Contact details for Australian, state and territory 


Following significant exposure (percutaneous, ocular or mucous membrane) to 

blood or to potentially blood-contaminated secretions, where feasible, the source 

individual should be tested for HBsAg as soon as possible. 

If the person exposed has not been previously vaccinated against hepatitis B, 

their anti-HBs level, and anti-HBc and HBsAg status, should be determined 

immediately. If the person exposed is anti-HBs and anti-HBc negative (nonimmune) 

and the source is either HBsAg-positive or cannot be identified and 

tested rapidly, a single dose of HBIG should be administered according to 

the recommendations in Table 4.5.3. The dose of HBIG is 100 IU for children 

weighing up to 30 kg (about 5 years of age) and 400 IU for all others. Hepatitis B 

vaccine must also be given as soon as possible, with further doses as 

recommended in Table 4.5.3. 

For previously vaccinated persons exposed to either an HBsAg-positive source 

or a source whose hepatitis B status cannot be determined, post-exposure 

prophylaxis is not necessary if there was a documented protective response (anti- 

HBs level ≥10 mIU/mL) at any time after vaccination. If the response to previous 

vaccination is unknown, the anti-HBs level should be determined as quickly as 

possible. If the anti-HBs level is

Table 4.5.3: Post-exposure prophylaxis for non-immune persons exposed to a 

HBsAg-positive source 

Type of exposure Hepatitis B immunoglobulin Vaccine 

Perinatal 

(exposure of 

babies during and 

after birth)* 

Percutaneous, 

ocular or mucous 

membrane 

100 IU, by 

IM injection 

400 IU, by 

IM injection 

100 IU, 

if body 

weight 






4.6 HUMAN PAPILLOMAVIRUS 


Human papillomaviruses (HPVs) are small, non-enveloped viruses with circular 

double-stranded DNA. HPVs infect and replicate primarily within cutaneous 

and mucosal epithelial tissues. 

More than 100 HPV genotypes have been identified based on sequence variations 

in the major genes. They differ in their preferred site of infection; approximately 

40 HPV types infect the anogenital tract. Some HPV types, including types 16, 

18, 31, 33, 35, 45, 52 and 58, are designated as ‘high-risk’, as they are causally 

associated with the development of cancer. Other HPV types, including types 

6, 11, 40, 42, 43, 44, 54, 61, 70, 72, 81 and 89, have been classified as ‘low-risk’ 

and are predominantly associated with non-malignant lesions, such as genital 

warts. The other types are uncommon and their associations with disease are 

undetermined, but they are not currently believed to be significant causes of 

cancer. 1,2 


Transmission of anogenital HPV occurs primarily through sexual intercourse; 

however, virus transmission can less commonly occur following non-penetrative 

sexual contact. 3 Perinatal transmission of HPV can cause laryngeal infection in 

infants, rarely resulting in recurrent respiratory papillomatosis. 4 HPV infection is 

often subclinical, but, dependent upon the infecting HPV genotype, may result 

in lesions that include cutaneous warts, genital warts, respiratory papillomatosis 

(low-risk HPV types), and dysplasias and cancers of the cervix, vulva, vagina, 

penis, anus, and the oral cavity and oropharynx (high-risk HPV types). Most 

genital HPV infections are cleared (no longer detectable via HPV DNA testing) 

within 12 to 24 months. In about 3 to 10% of infections, the virus persists. Persons 

with persistent HPV infection constitute the at-risk group for development of 

HPV-associated cancers. 5-7 

The causal link between persistent cervical HPV infection and cervical cancer is 

well established. The strength of association between HPV infection and other 

cancers varies by site and oncogenic HPV type. 8 

Cellular changes that occur in the cervix as a result of HPV infection are referred 

to as cervical intraepithelial neoplasia (CIN). The majority of these changes 

regress, but a minority will progress to cervical cancer. Malignant transformation 

in the cervix usually occurs 10 to 20 years following infection with high-risk HPV 

types, but has been reported to occur in less than 2 years. 9 

The clinical features of other HPV-associated cancers and their precursor lesions 

in the anogenital region and oropharynx vary, and also depend on the anatomical 

site. The process of progression of HPV-associated precursor lesions to cancers 

in these sites is less well understood than the process in the cervix. Anogenital 

warts may present as painless lumps, or with local tenderness, itching or 


4.6 HUMAN PAPILLOMAVIRUS

leeding. Recurrent respiratory papillomatosis is a potentially fatal condition that 

usually occurs in childhood, characterised by multiple warty excrescences on the 

mucosal surface of the respiratory tract. 10 


Infection with HPV is very common in both men and women, with initial 

infection occurring close to the time of sexual debut. It is estimated that up to 

79% of the general population will be infected with at least one genital type 

of HPV at some time in their lives. 11,12 A greater number of sexual partners is 

consistently found to be associated with an increased risk of HPV acquisition. 12 

HPV infection rates differ between geographic regions, and estimated 

population prevalence of HPV also varies depending on the anatomical site and 

the lesions sampled. About two-thirds of Australian women aged 15–20 years 

participating in cervical screening had HPV DNA detected in cervical samples 

collected for cytology. 13 

Certain population subgroups are identified to be at increased risk of 

HPV infection and HPV-associated diseases, compared with the general 

population. Infection with multiple HPV genotypes and longer time to clear 

infection are commonly observed in men who have sex with men (MSM). 14-16 

In addition, the prevalence of high-risk HPV types is significantly higher in 

HIV-positive MSM than in MSM who are HIV-negative. 14 Persons who are 

immunocompromised (due to disease or medical treatment) are at increased 

risk of HPV-related disease. 12 

In a serosurvey conducted in Australia in 2006, 24% of females and 18% of males 

aged 0–69 years were seropositive to at least one of the four HPV types 6, 11, 16 

and 1817 – noting that fewer than 60% of women, and an even lower proportion 

of men, who are infected with HPV develop antibodies. 18-20 The onset age of 

seropositivity for HPV in this study was 10–14 years in females and 15–19 years 

in males. The average age of sexual debut for both males and females in Australia 

was 16 years, as reported in 2000–2002. 21 A more recent national survey in 2008 

reported that about 80% of senior secondary school children (aged approximately 

15–19 years) acknowledged having engaged in some form of sexual activity that 

may transmit HPV. 22 

Persistent HPV infection is the necessary precursor for the development 

of all cervical cancers. 23 Worldwide, approximately 70% of cervical cancers 

contain HPV-16 DNA and 16% contain HPV-18 DNA. 24,25 Australian data 

indicate that HPV-16 and HPV-18 are responsible for approximately 60% and 

20%, respectively, of cervical cancers, and 37% and 8%, respectively, of highgrade 

cervical abnormalities. 26,27 In Australia, cervical cancer ranked 22nd in 

the overall cancer disease burden in 2008 and now occurs predominantly in 

women unscreened or under-screened through the National Cervical Screening 

Program. 28,29 In 2007, the age-standardised incidence rate of cervical cancer in 

Australia was 6.8 per 100 000, and the mortality rate was 1.8 deaths per 100 000 


women. The prevalence of high-risk HPV types 16 and 18, detected when 

cervical samples collected for cytology were tested for HPV DNA, was similar 

between Indigenous and non-Indigenous women. 13 However, the incidence rate 

of cervical cancer in Aboriginal and Torres Strait Islander women is almost 3 

times higher than in non-Indigenous Australian women, an indication of lower 

participation rates in cervical screening programs by Indigenous Australians and 

greater prevalence of cofactors for cervical cancer such as smoking, earlier and 

more pregnancies, and lower socioeconomic status. 13,28,30 Indigenous women are 

5 times more likely to die from cervical cancer than non-Indigenous women. 28 

Also, Australians in remote and very remote areas have 1.5 times higher cervical 

cancer incidence than those living in major cities. 28 

The proportion of cancers of other anogenital sites that is attributable to HPV 

ranges from approximately 40% for vulval cancers to approximately 85% for 

anal cancers. More than 85% of these HPV-associated cancers have evidence of 

infection due to the high-risk HPV types 16 and 18. 31-36 

In Australia in 2007, incidence rates of vulval and vaginal cancers in women were 

2.6 per 100 000 (n=276) and 0.65 per 100 000 (n=69), respectively. 28 The incidence 

rate of penile cancer was 0.8 per 100 000. The age-standardised incidence rate 

for anal cancer was 1.3 per 100 000; however, a slightly higher incidence was 

observed in females than in males. Overall, anal cancer incidence has been 

steadily increasing over the past few decades; however, the increase has been 

greater in males than in females. 31,34 The mortality rates for vulval, vaginal, penile 

and anal cancers were all less than 0.6 per 100 000. 28 

MSM have a significantly higher incidence of high-grade anal intraepithelial 

neoplasia and anal cancer than the general population. Overseas studies have 

found a greater than 30-fold higher incidence of anal cancer in MSM than in 

other men. 37,38 

There is wide variability in the reported proportions of oropharyngeal cancers 

associated with HPV, ranging from 12% to 63%, and a lower proportion of oral 

cancers. 39-41 Of the cancers at these sites that are HPV-positive, HPV-16 and/or 

HPV-18 account for more than 85%. In Australia, similar to the United States and 

other western countries, there has been a steady increase in the burden of HPVpositive 

oropharyngeal cancers (mainly attributable to cancers of the base of the 

tongue and tonsils) over the past few decades. 31,39,42-45 

The population incidence of benign HPV-associated lesions, such as anogenital 

warts, is much higher than the incidence of HPV-associated cancers. In Australia, 

the estimated annual incidence of anogenital warts in 2000–2006 was 206 per 

100 000 in males and 231 per 100 000 in females. The age group of peak incidence 

was 25–29 years for men (rate 740 per 100 000) and 20–24 years for women (rate 

861 per 100 000). 46 In Australia, 4.0% of men and 4.4% of women aged 16–59 

years reported ever being diagnosed with genital warts, 47 and the estimated 

cumulative lifetime risk of genital warts was 10%. 48,49 The estimated incidence of 



anogenital warts in MSM is about 10 times higher than in the general population, 

with a third of HIV-negative MSM reporting a history of these lesions. 46,50 HPV 

types 6 and 11 are associated with 90% of genital warts. 51,52 

Recurrent respiratory papillomatosis is a rare (incidence approximately 3.5 per 

100 000) and predominantly childhood disease that is associated with HPV types 

6 and 11 in 100% of cases. 52-54 

In 2007, the HPV Vaccination Program, funded under the NIP, was introduced. 

This initially included universal vaccination of girls aged approximately 

12–13 years, delivered through an ongoing school-based program. It also 

included a catch-up program for females up to 26 years of age, which ceased at 

the end of 2009. In 2013, the program will be extended to include HPV vaccine 

for boys aged approximately 12–13 years, together with a 2-year catch-up 

program for Year 9 boys. Although the impact of HPV vaccination on cancer 

incidence will take decades to occur, early surveillance data have shown an 

impact on the incidence of genital warts and CIN in the years following the 

introduction of the female vaccination program. 55-58 A study including eight 

sexual health centres showed a 59% decrease in the proportion of vaccineeligible 

female first-time clinic attendees diagnosed with genital warts. 56 This 

study also demonstrated that vaccination of females results in some herd 

immunity benefits to males, with a significant decline in the diagnosis of genital 

warts observed in unvaccinated males of the same age. 55,56,58 In addition to 

reduction in genital warts, Victorian data have demonstrated a 48% decline in 

the incidence of high-grade cervical abnormalities in girls aged

• Gardasil – CSL Limited/Merck & Co Inc (recombinant protein 

particulate [VLP] vaccine containing the major capsid [L1] protein 

of HPV types 6, 11, 16 and 18; 4vHPV). Each 0.5 mL monodose 

vial or pre-filled syringe contains 20 µg HPV-6 L1 protein, 40 µg 

HPV-11 L1 protein, 40 µg HPV-16 L1 protein and 20 µg HPV-18 

L1 protein, adsorbed onto 0.225 mg of aluminium as aluminium 

hydroxyphosphate sulphate; 0.780 mg L-histidine; 50 µg polysorbate 

80; 35 µg sodium borate. May also contain yeast proteins. 

The 2vHPV and 4vHPV vaccines have been assessed in females in a number 

of international clinical trials. When given as a 3-dose series, HPV vaccines 

elicit a neutralising antibody level many times higher than the level observed 

following natural infection. 61,62 Overall, seroconversion occurs in 97 to 100% 

of those vaccinated. 63-65 In women who are naïve to HPV types 16 and 18 prior 

to vaccination, both vaccines are highly effective at preventing type-specific 

persistent infection and related cervical disease (approximately 90 to 100%). 66-71 

The 4vHPV vaccine also has established efficacy (100%; 95% CI: 94–100%) 

against external anogenital and vaginal lesions (genital warts, and vulval, 

vaginal, perineal and perianal dysplasias) associated with HPV types 6, 11, 

16 or 18 in women. 

In women who are vaccinated irrespective of their baseline HPV status (i.e. 

women who may have pre-existing HPV infection), vaccine efficacy is lower than 

observed in HPV-naïve women, indicating reduced vaccine effectiveness among 

women who are already sexually active. This is because both HPV vaccines are 

prophylactic vaccines (i.e. preventing primary HPV infection). Vaccination will 

not treat an existing HPV infection or prevent disease that may be caused by an 

existing HPV vaccine-type infection. 63,72,73 However, vaccination may still provide 

benefit for sexually active women by protecting them against new infections with 

other vaccine-preventable HPV types. 

The efficacy of 4vHPV in males aged 16–26 years has been demonstrated 

in one clinical trial. 74 Vaccination was greater than 85% protective against 

persistent anogenital infection and external genital lesions due to vaccine HPV 

types among HPV-naïve participants. Among HPV-naïve MSM participants 

within the clinical trial, vaccine efficacy was 95% against intra-anal HPV 

infection and 75% against high-grade anal intraepithelial neoplasia from 

vaccine HPV types. Efficacy of 2vHPV vaccine in males has not been assessed 

to date; however, the vaccine has demonstrated safety and immunogenicity in 

males aged 10–18 years. 75 

There is some evidence of HPV vaccine providing some cross-protection to 

disease due to other HPV types in women: 4vHPV vaccine against cervical 



disease due to HPV types 31 and 4576 and 2vHPV vaccine against cervical disease 

due to HPV types 31, 33, 45 and 51. 77 However, the level of protection is less than 

for the vaccine HPV types and the durability of any such protection is unknown. 

Efficacy of HPV vaccines in females or males 9 years of age) were greater than those in adult women and 

men, in whom clinical efficacy has been demonstrated for both the 4vHPV and 

2vHPV vaccines. 

It is not certain how long immunity following HPV vaccination persists, or 

whether a booster dose after the primary course will ever be required. However, 

long-term population-based follow-up studies to assess this are underway. 78 

In clinical trials, vaccine efficacy has been demonstrated up to at least 5 years 

for 4vHPV vaccine and 9.4 years for 2vHPV vaccine in women, with no 

breakthrough disease due to vaccine HPV types. 61,79,80 

Variations in vaccination schedules for both HPV vaccines are being assessed 

in clinical trials. A recent study showed a lesser immune response in a schedule 

with a dose interval of 12 months between each of the 3 doses of 4vHPV vaccine 

compared with schedules with dose intervals of 6 months or less between each of 

the doses. 81 However, a recent study of 2vHPV following an alternative schedule 

(0, 1 and 12 months) demonstrated that the immunogenicity of vaccine HPV 

types was non-inferior following this schedule, compared with the standard 

schedule (measured 1 month after the final dose). 82 Two-dose schedules of both 

2vHPV and 4vHPV are also being studied. 83,84 





The dose of both HPV vaccines is 0.5 mL to be given by IM injection. 

The primary vaccination course for both HPV vaccines consists of 3 doses. 

The recommended schedule for the 2vHPV vaccine is at times 0 (the day the 

1st dose is given), 1 and 6 months. The 2vHPV vaccine is registered for use in 

females aged 10–45 years. The 2vHPV vaccine is not registered for use in males 

of any age. 

The recommended schedule for the 4vHPV vaccine is at times 0 (the day the 

1st dose is given), 2 and 6 months. The 4vHPV vaccine is registered for use in 

females aged 9–45 years and in males aged 9–26 years. However, there are no 

theoretical concerns that the efficacy or safety of 4vHPV vaccine in males up 

to the age of 45 years will differ significantly from females of the same age or 

younger males. 


If scheduled doses have been missed, there is no need to repeat earlier doses. 

The missed dose(s) should be given as soon as is practicable, making efforts to 

complete doses within 12 months. 

Where vaccines have been administered at less than the minimum intervals (see 

Table 2.1.12 Catch-up schedule for persons ≥10 years of age (for vaccines recommended 

on a population level)), contact your state or territory health department for 

guidance. See also Chief Medical Officer Guidance available at www.health.gov. 

au/internet/immunise/publishing.nsf/Content/cmo-full-advice-hpv-cnt. 


Both HPV vaccines can be given concomitantly with reduced antigen content 

diphtheria-tetanus-acellular pertussis (dTpa) or diphtheria-tetanus-acellular 

pertussis-inactivated poliomyelitis vaccine (dTpa-IPV), and hepatitis B vaccine 

(monovalent). 86-90 There are no clinical data regarding concomitant administration 

of either HPV vaccine with varicella vaccine, but there are no theoretical concerns 

about safety or efficacy of the vaccines if they are given simultaneously, using 

different injection sites. 

Interchangeability of human papillomavirus vaccines 

There are currently no clinical data available on the interchangeability of the 

two HPV vaccines. However, from first principles, acceptable antibody levels 

and protection against HPV-16 and 18 (the types that are shared by both these 

vaccines and that are the dominant causes of cervical cancer) would be expected 

following a combination schedule. 

It is recommended that an HPV vaccination course commenced with one vaccine 

should, wherever possible, be completed with that vaccine and according to its 

recommended schedule. 

Where the course includes a combination of the two HPV vaccines, either 

inadvertently or because of an adverse event following one vaccine, the person 

is considered to be fully immunised against HPV-16 and 18 disease if a total of 

3 doses of HPV vaccine have been given, provided that the minimum interval 

requirements between the doses are satisfied. Every effort should be made to 

complete a 3-dose schedule for effective protection against disease due to each of 

the vaccine HPV types. 


Neither HPV vaccine is registered or recommended for use in children

Children and adolescents aged 9–18 years 

HPV vaccine is recommended for females 9–18 years of age. The optimal age 

for administering the HPV vaccine is approximately 11–13 years, as most 

females in this age group would not have commenced sexual activity and so 

would be naïve to all HPV types. Vaccination only provides protection against 

vaccine-type disease if the vaccine is delivered prior to acquisition of that HPV 

type. Therefore, the decision to vaccinate older adolescent females, who may 

have already commenced sexual activities, should follow an assessment of the 

potential benefits, based on their likely previous HPV exposure and future risks 

of HPV exposure. 

Either of the HPV vaccines can be used for adolescent females. The 2vHPV 

vaccine is only registered for use in girls ≥10 years of age. 

Adults aged ≥19 years 

Vaccination of all women in this age group is not routinely recommended, as 

many are likely to have been exposed to one or more vaccine HPV types through 

sexual activity (see 4.6.3 Epidemiology above). 

However, some adult females may gain an individual benefit from HPV 

vaccination. The decision to vaccinate older females should take into account 

their likelihood of previous exposure to HPV and their future risks of HPV 

exposure. 

Males 

The 4vHPV vaccine is recommended for use in males for prevention of persistent 

infection and anogenital disease caused by HPV types 6, 11, 16 and 18. The 

4vHPV vaccine also provides protection against vaccine-type genital warts 

(which are mostly caused by HPV types 6 and 11). (See also 4.6.4 Vaccines above.) 

Children and adolescents aged 9–18 years 

The 4vHPV vaccine is recommended for males 9–18 years of age. The optimal 

age for administering the 4vHPV vaccine is approximately 11–13 years, as most 

males in this age group would not have commenced sexual activity and so 

would be naïve to all HPV types. Vaccination only provides protection against 

vaccine-type disease if the vaccine is delivered prior to acquisition of that HPV 

type. Therefore, the decision to vaccinate older adolescent males, who may 

have already commenced sexual activities, should follow an assessment of the 

potential benefits, based on their likely previous HPV exposure and future risks 

of HPV exposure. 


Vaccination of all men in this age group is not routinely recommended as many 

are likely to have been exposed to one or more vaccine HPV types through sexual 

activity (see 4.6.3 Epidemiology above). 


However, some adult males may gain an individual benefit from HPV 

vaccination. The decision to vaccinate older males should take into account their 

likelihood of previous exposure to HPV and their future risks of HPV exposure. 

Men who have sex with men 

The 4vHPV vaccine is recommended for men who have sex with men (MSM) 

who have not previously been vaccinated with 3 doses of HPV vaccine. The 

decision to vaccinate males in this group should take into account their likelihood 

of previous exposure to HPV and their future risks of HPV exposure. Overall, 

MSM are at increased risk of persistent HPV infection and associated disease 

(independent of HIV status or the presence of other immunocompromising 

conditions). 14,38 In addition, at the population level, MSM are less likely to benefit 

from herd immunity attained from HPV vaccination of females. The safety and 

efficacy of 4vHPV vaccine has been demonstrated in MSM participants in a 

randomised clinical trial (see 4.6.4 Vaccines above). 

Persons who are immunocompromised 

HPV vaccine is recommended for adult men and women who are 

immunocompromised due to medical conditions (including HIV infection) or 

treatment. The decision to vaccinate immunocompromised persons should take 

into account their likelihood of previous exposure to HPV, their future risks 

of HPV exposure, and the extent and duration of their immunocompromise 

(see 3.3.3 Vaccination of immunocompromised persons). Immunocompromised 

adolescents who have not yet been vaccinated with 3 doses of HPV vaccine 

should be offered catch-up vaccination. This is based on evidence that persons 

who are immunocompromised are more likely to develop a persistent HPV 

infection and to subsequently progress to HPV-related disease. 14,91 

There are currently no clinical trial data demonstrating the efficacy of either of 

the HPV vaccines in immunocompromised participants. However, 4vHPV has 

been shown to be well tolerated and immunogenic in HIV-infected males and 

women with systemic lupus erythematosus. 92-94 As HPV vaccines are not live 

viral vaccines, there are no specific safety concerns regarding administration 

to immunocompromised persons (see 3.3.3 Vaccination of immunocompromised 

persons). 

Cervical screening in vaccinated females 

For all sexually active women, regular cervical screening remains an important 

preventive measure against cervical disease (refer to the National Cervical 

Screening Program at www.cancerscreening.gov.au). Vaccination is not an 

alternative to cervical screening but is a complementary preventive measure, as 

HPV types other than those included in the current vaccines have the potential 

to cause cervical cancer. Likewise cervical screening is not an alternative to HPV 

vaccination. Both are recommended. 



Cervical screening detects histopathological changes. It is not recommended to 

test for the presence of HPV virus or antibody routinely as a way of determining 

whether HPV vaccination is indicated. 

For women who have recently been diagnosed with cervical dysplasia, or have 

been treated for this in the past, HPV vaccine will have no impact on current 

disease, but may prevent future dysplasia due to different HPV types included in 

the vaccine. 


HPV vaccines are not recommended for pregnant women. 

Women who become pregnant after starting the HPV vaccination course should 

withhold getting further doses of the HPV vaccine while pregnant, and receive 

the remaining doses of the course after pregnancy. 

Females who inadvertently receive a dose of HPV vaccine around the time of 

conception or during pregnancy should be informed of the body of evidence 

supporting lack of harm from vaccine administration in this setting. Among 

women who became pregnant during the course of 4vHPV vaccine clinical trials 

(despite recommendations for participants to avoid pregnancy), the overall 

proportions of pregnancies that resulted in an adverse outcome (spontaneous 

abortion, late fetal death, infant with congenital anomalies) were similar among 

4vHPV vaccine recipients and placebo or control vaccine recipients. Although 

one clinical trial raised the possibility of an association between 4vHPV vaccine 

administered within 30 days following the estimated date of conception and an 

increased incidence of congenital anomalies in the infant, those conditions were 

relatively common and unrelated. 72 Pooled analyses from multiple clinical trials 

have not confirmed such an association. 95 

Pooled analysis of women who became pregnant during clinical trials showed 

that, overall, there were no differences in pregnancy outcomes between 2vHPV 

vaccine and control vaccine recipients. 96,97 

HPV vaccines can be given to breastfeeding women. Among breastfeeding 

mothers in the clinical studies of 4vHPV vaccine, the rates of adverse events 

in the mother and the breastfeeding infant were comparable between 4vHPV 

vaccine and control vaccination groups. 98 The effect on breastfed infants of 

the administration of 2vHPV vaccine to their mothers has not been evaluated 

directly in clinical studies, but breastfeeding is not considered a contraindication 

for receiving the 2vHPV vaccine. 





The only absolute contraindications to HPV vaccines are: 

• anaphylaxis following a previous dose of either HPV vaccine 


In particular, the 4vHPV vaccine is contraindicated in persons with a history of 

anaphylaxis to yeast. 


Both the 2vHPV and 4vHPV vaccines are generally safe and well tolerated. 

For both vaccines, injection site pain was the most commonly reported adverse 

event (approximately 80% of recipients), followed by swelling and erythema 

(20–30% for each). Injection site reactions were more commonly reported in 

vaccine recipients than in recipients of aluminium-containing placebo or control 

vaccines in clinical trials. Systemic reactions were also very common following 

both vaccines, occurring in up to about 30% of recipients. The most common 

adverse events included headache, fatigue, fever and myalgia. In most of the 

clinical trials, the frequencies of most of these common systemic adverse events 

were comparable between the HPV vaccine and the control vaccine recipients. 

Meta-analyses on pooled data from multiple clinical trials on both the 2vHPV 

and 4vHPV vaccines have shown no increase in the risk of serious adverse events 

among vaccine recipients compared with control recipients. 99,100 

For both vaccines, the safety profile and the spectrum of adverse events 

following immunisation in males were similar to those reported in females of 

corresponding age groups, 74,75,101,102 although some of the studies were not direct 

comparison studies. 

Post-marketing passive surveillance of HPV vaccine use in the United States has 

identified syncope (fainting) as one of the most common adverse events reported 

following 4vHPV vaccine in adolescent and young adult females. 103 A small 

proportion (about 10%) of syncopal episodes resulted in a fall with head injury. 103 

Similar or higher rates of syncope have been reported in other countries, through 

different surveillance mechanisms. 104,105 However, a prospective adverse events 

surveillance study in the United States, based on over 600 000 records of vaccine 

doses administered, did not find any increased risk of syncope with 4vHPV 

vaccination compared to the expected rate following non-4vHPV vaccination in 

youths and adults. 106 Syncope (fainting) may follow any vaccination, especially 

in adolescents and young adults, but is preventable through appropriate 

precautions. (See also 2.3.2 Adverse events following immunisation). In an Australian 

study, 22 subjects (including 14 with syncope and 8 with syncopal seizure 

following 4vHPV vaccination) were reviewed in a Victorian clinic and received 

further doses while supine; no recurrence of syncope occurred. 104 

Anaphylaxis and other suspected hypersensitivity reactions, including skin 

rash, after 4vHPV vaccine have also been reported. The estimated incidence 



ate of anaphylaxis following 4vHPV vaccine in Australia, as at June 2010, was 

2.6 anaphylaxis episodes per million doses of vaccine distributed, which was 

within the rate range for other vaccines given to children and adolescents in 

international studies. 107 A prospective surveillance study in the United States 

did not find any increased risk of anaphylaxis or allergic reactions with 4vHPV 

vaccination compared to the expected rate following childhood vaccines. 106 


The product information for the 4vHPV vaccine, Gardasil, states that this 

vaccine is indicated for use in males up to 26 years of age and females up to 

45 years of age. The product information for the 2vHPV vaccine, Cervarix, 

states that this vaccine is indicated for use in females up to 45 years of 

age and is not registered for use in males of any age. The ATAGI instead 

recommends that some males aged >26 years, such as MSM and those who are 

immunocompromised, who are likely to derive an individual benefit from HPV 

vaccination, can be vaccinated with 4vHPV. The ATAGI also recommends that 

some females aged >45 years, such as those who are immunocompromised, can 

be vaccinated with either 2vHPV or 4vHPV, based on their individual risk of 

future HPV exposure and disease. 

References 




4.7 INFLUENZA 


The influenza viruses are single-stranded RNA orthomyxoviruses. They are 

classified antigenically as types A, B or C, but only influenza A and B are 

clinically important in human disease. 1 Influenza viruses possess two surface 

glycoprotein antigens: the haemagglutinin (H), which is involved in cell 

attachment during infection, and the neuraminidase (N), which facilitates the 

release of newly synthesised virus from the cell. Influenza A viruses can be 

classified into subtypes based on differences in these surface antigens, whereas 

influenza B cannot. Antibody against the surface antigens, particularly the 

haemagglutinin, reduces infection or severe illness due to influenza. 

Both influenza A and influenza B viruses undergo frequent changes in their 

surface antigens, involving stepwise mutations of genes coding for H and N 

glycoproteins. This results in cumulative changes in influenza antigens, or 

‘antigenic drift’, which is responsible for the annual outbreaks and epidemics of 

influenza and is the reason that the composition of influenza vaccines requires 

annual review. ‘Antigenic shift’, defined as a dramatic change in influenza A 

H (and other) antigen, occurs occasionally and unpredictably and can cause 

pandemic influenza. 1 Pandemic subtypes arise following antigenic shift, which 

is due to direct adaptation to humans of an avian or animal virus, or to this 

adaptation occurring by genetic reassortment (mixing) with a human virus. 


Influenza is transmitted from person to person by virus-containing respiratory 

aerosols produced during coughing or sneezing, or by direct contact with 

respiratory secretions. 1,2 Influenza virus infection causes a wide spectrum of 

disease, from no or minimal symptoms, to respiratory illness with systemic 

features, to multisystem complications and death from primary viral or 

secondary bacterial pneumonia. Severe disease is more likely with advanced 

age; lack of previous exposure to antigenically related influenza virus; greater 

virulence of the viral strain; chronic conditions, such as heart or lung disease, 

renal failure, diabetes and chronic neurological conditions; immunocompromise; 

pregnancy; and smoking. In pandemics, severe disease may also occur in 

otherwise healthy young adults. Annual attack rates in the general community 

are typically 5 to 10%, but may be up to 20% in some years. In households 

and ‘closed’ populations, attack rates may be 2 to 3 times higher. 3,4 However, 

as asymptomatic or mild influenza illness is common and symptoms are nonspecific, 

a large proportion of influenza infections are not detected. 

In adults, the onset of illness due to influenza is often abrupt, usually after an 

incubation period of 1 to 3 days, and includes systemic features such as malaise, 

feverishness, chills, headache, anorexia and myalgia. These may be accompanied 

by a cough, nasal discharge and sneezing. Fever is a prominent sign of infection 


4.7 INFLUENZA

and peaks at the height of the systemic illness. Symptoms are similar for 

influenza A and B viruses. However, infections due to influenza A (H3N2) 

strains are more likely to lead to severe morbidity and increased mortality than 

influenza B or seasonal influenza A (H1N1) strains. 1,2 

The clinical features of influenza in infants and children are similar to those 

in adults. However, temperatures may be higher in children (and may result 

in febrile convulsions in this susceptible age group), and otitis media and 

gastrointestinal manifestations are more prominent. 5 Infection in young infants 

may be associated with more non-specific symptoms. 5,6 

Complications of influenza include: acute bronchitis, croup, acute otitis 

media, pneumonia (both primary viral and secondary bacterial pneumonia), 

cardiovascular complications including myocarditis and pericarditis, 

post-infectious encephalitis, Reye syndrome, and various haematological 

abnormalities. Primary viral pneumonia occurs rarely, but secondary bacterial 

pneumonia is a frequent complication in persons whose medical condition makes 

them vulnerable to the disease. Such persons are at high risk in epidemics and 

may die of pneumonia or cardiac decompensation. 


In most years, minor or major epidemics of type A or type B influenza occur, 

usually during the winter months in temperate regions. In Australia, although 

an average of 85 deaths and approximately 4000 hospitalisations directly 

attributed to influenza are notified annually, it has long been recognised that 

this is a substantial underestimate of the impact of influenza. 7 It is estimated that 

there are an average of over 13 500 hospitalisations due to influenza per year in 

Australia and over 3000 deaths per year in Australians aged over 50 years alone. 8 

Influenza activity varies from year to year and is dependent on the circulating 

virus and the susceptibility of the population. 8,9 For example, there were over 

10 000 confirmed cases of influenza reported to the National Notifiable Diseases 

Surveillance System in the first half of 2011, compared with approximately 1570 

for the same period in 2010. 2 Laboratory testing for influenza has also increased 

in recent years. In Australia, like other developed countries, the highest influenza 

burden is seen in the elderly and in children

Figure 4.7.1: Influenza notification rates 2006–2007* and hospitalisation rates 

2005–2007,* Australia, by age group 9 

Rate per 100 000 population 

120 

100 

80 

60 

40 

20 

0 

0–4 

5–9 

10–14 

15–19 

20–24 


25–29 

250 

200 

150 

100 

50 

30–34 

0 

35–39 

0 1 2 

Age (years) 

3 4 

40–44 

45–49 

50–54 

Age (years) 

55–59 

Notifications 

Hospitalisations 

* Notifications where the month of diagnosis was between January 2006 and December 2007; 

hospitalisations where the month of separation was between July 2005 and 30 June 2007. These 

data are prior to the appearance of the pandemic A(H1N1)pdm09 virus in 2009. 

Three pandemics were recognised in the 20th century, in 1918 (H1N1), 

1957 (H2N2) and 1968 (H3N2). Each of these pandemic strains replaced the 

previously circulating influenza A subtype and went on to circulate as seasonal 

influenza. In 1977, the A (H1N1) re-emerged in the human population and, since 

then, A (H1N1) and A (H3N2) have co-circulated with influenza B. Recently, 

the avian influenza A virus subtypes, H5N1 and H9N2, have caused human 

infections. The most notable of these is the A (H5N1) subtype, which has become 

established in domestic poultry throughout Southeast Asia and has spread to 

Europe and Africa in either wild birds or domestic poultry. Although growing 

numbers of people have contracted the virus by contact with birds and there is 

a high mortality rate (≥50%), there has been no evidence of ongoing person-toperson 

transmission. 

In 2009, the World Health Organization (WHO) declared a pandemic of a novel 

subtype A (H1N1) influenza virus, A(H1N1)pdm09, which originated in swine; 

the pandemic started in Mexico and the United States in April 2009. In August 

2010, the WHO reported that more than 214 countries and overseas territories or 

60–64 

65–69 

70–74 

75–79 

80–84 

85 


4.7 INFLUENZA

communities reported laboratory-confirmed cases of A(H1N1)pdm09 (pH1N1) 

influenza, including more than 18 000 deaths. 14 In Australia, a total of 44 403 

confirmed cases of pH1N1 influenza occurred between May 2009 and November 

2010, including 6767 cases in 2010. A total of 213 pandemic influenza-associated 

deaths were reported, 22 of which occurred in 2010. 15 

Evidence from multiple outbreak sites demonstrated that the A(H1N1)pdm09 

virus rapidly established itself and was the dominant influenza strain in most 

parts of the world. The clinical picture of pH1N1 influenza appeared to be largely 

consistent across all countries, with most affected persons experiencing moderate 

illness. Risk factors for severe disease included obesity, pregnancy, diabetes 

mellitus and, in Australia, being of Aboriginal or Torres Strait Islander descent 

(see 3.1 Vaccination for Aboriginal and Torres Strait Islander people). Although 

influenza can cause very severe and fatal illness, particularly in the elderly, the 

impact of pH1N1 influenza in younger healthy adults and in pregnant women 

was proportionally greater than normal seasonal outbreaks, even though the 

absolute number of such cases remained low. During the last quarter of 2009, 

Australia introduced a non-adjuvanted, inactivated, egg-derived, monovalent 

A(H1N1)pdm09 vaccine for administration to all persons aged ≥6 months 

(Panvax, CSL Limited). Expired monovalent vaccine supplies were withdrawn 

in December 2010. 16 In Australia, there was ongoing summer activity of A(H1N1) 

pdm09 in late 2009, and the virus continued to circulate in 2010 and 2011, 

replacing the previously circulating seasonal H1N1 strain. 2 The A(H1N1)pdm09 

strain was included in trivalent seasonal influenza vaccine formulations used in 

the southern hemisphere in 2010, 2011 and 2012. 


The administration of influenza vaccine to persons at risk of complications of 

infection is the single most important measure in preventing or attenuating 

influenza infection and preventing mortality. After vaccination, most adults 

develop antibody levels that are likely to protect them against the strains of 

virus represented in the vaccine. In addition, there is likely to be protection 

against many related influenza variants. Infants, the very elderly, and persons 

who are immunocompromised may develop lower post-vaccination antibody 

levels. Under these circumstances, influenza vaccine may be more effective 

in preventing lower respiratory tract involvement or other complications of 

influenza than in preventing influenza infection. 


Always check annual seasonal influenza vaccine availability statements 

on www.immunise.health.gov.au. Vaccines and age eligibility change 

from year to year. 

Vaccines for intramuscular administration 

Children aged ≥6 months and adults (see Table 4.7.1 for dosage information for 

different age groups) 

• Agrippal – Novartis Vaccines and Diagnostics Pty Ltd (inactivated 

influenza virus). Each 0.5 mL pre-filled syringe contains 15 µg 

haemagglutinin of each of the three recommended strains. May 

contain traces of kanamycin, neomycin, formaldehyde, barium 

sulphate, cetrimonium bromide (CTAB), polysorbate 80 and egg 

protein. 

• Fluarix – GlaxoSmithKline (inactivated influenza virus). Each 0.5 mL 

pre-filled syringe contains 15 µg haemagglutinin of each of the 

three recommended strains. May contain traces of formaldehyde, 

gentamicin, polysorbate 80, octoxinol 10 and egg protein. 

• Influvac – Abbott Products Pty Ltd (inactivated influenza virus). Each 

0.5 mL pre-filled syringe contains 15 µg haemagglutinin of each of 

the three recommended strains. May contain traces of formaldehyde, 

CTAB, polysorbate 80, gentamicin and egg protein. 

• Influvac Junior (6 months to

Children aged ≥10 years* and adults (see Table 4.7.1 for dosage information) 

• Fluvax – CSL Limited (inactivated influenza virus).* Each 0.5 mL 

pre-filled syringe contains 15 µg haemagglutinin of each of the three 

recommended strains. May contain traces of neomycin, polymyxin B, 

β-propiolactone, sodium taurodeoxycholate and egg protein. 


• Fluad – Novartis Vaccines and Diagnostics Pty Ltd (inactivated 

influenza virus). Each 0.5 mL pre-filled syringe contains 15 µg 

haemagglutinin of each of the three recommended strains, adjuvanted 

with MF59C.1 (which contains squalene and polysorbate 80). May 

contain traces of kanamycin, neomycin, formaldehyde, barium 

sulphate, CTAB and egg protein. 

Vaccines for intradermal administration 

Adults aged 18–59 years 

• Intanza 9 μg – Sanofi Pasteur Pty Ltd (inactivated influenza virus). 

Each 0.1 mL pre-filled purpose-designed Micro-Injection System 

contains 9 µg haemagglutinin of each of the three recommended 

strains. May contain traces of formaldehyde, octoxinol 9, neomycin 

and egg protein. 


• Intanza 15 μg – Sanofi Pasteur Pty Ltd (inactivated influenza virus). 

Each 0.1 mL pre-filled purpose-designed Micro-Injection System 

contains 15 µg haemagglutinin of each of the three recommended 

strains. May contain traces of formaldehyde, octoxinol 9, neomycin 

and egg protein. 

* Fluvax (CSL Limited) is registered by the Therapeutic Goods Administration (TGA) for 

administration in children ≥5 years of age; however, it is not recommended for use in children 

7.5 µg of viral haemagglutinin (in a 0.25 mL dose) of each of the same three 

strains found in the adult formulations. 

All the influenza vaccines currently available in Australia are either split virion 

or subunit vaccines prepared from purified inactivated influenza virus that has 

been cultivated in embryonated hens’ eggs. Split virion and subunit vaccines 

are generally considered to be equivalent with respect to safety, and both 

are substantially free of the systemic reactions sometimes induced by whole 

virus vaccines. One exception is Fluvax (CSL Limited), which in 2010 resulted 

in higher rates of adverse events, specifically fevers and febrile convulsions, 

in children aged

efficacy varied by influenza season. 29 The efficacy of inactivated influenza vaccine 

against influenza-like illness in persons ≥65 years of age living in the community 

is estimated to be 43% when viral circulation is high, although there have been 

few randomised controlled trials of influenza vaccine in elderly people. 30 A 

systematic review assessing vaccine effectiveness estimated that during periods 

of high virus circulation, when vaccine match is good, influenza vaccination 

is approximately 45% effective against hospitalisations due to influenza and 

pneumonia and 60% effective against all-cause mortality in persons aged >65 

years in nursing home settings. 30 

Currently available influenza vaccines confer protection for about a year. Low 

levels of protection may persist for a further year, if the prevalent strain remains 

the same or undergoes only minor antigenic drift. 13,27 Continuing protection 

requires annual vaccination with vaccine containing the most recent strains. 




At the end of each year, influenza vaccines should be appropriately discarded 

to avoid inadvertently using a product with incorrect formulation in the 

following year. 


Vaccines registered by the TGA, and the ages for which they are indicated, 

can change from year to year. Always check annual seasonal influenza vaccine 

availability statements on www.immunise.health.gov.au, and consult individual 

product information. 

Influenza vaccines available in Australia for IM use are presented in pre-filled 

syringes, of either 0.5 mL or 0.25 mL. The dose of vaccine to be administered 

varies by age, with children aged 6 months to

Table 4.7.1: Recommended doses of influenza vaccine 

Age Dose Number of doses (first 

year of vaccination) 

Number of doses* 

(subsequent years) 

6 months to

All adults aged ≥65 years 

There is evidence that influenza vaccine reduces hospitalisations from influenza 

and pneumonia and all-cause mortality in adults ≥65 years of age. 30 (See also 

4.7.4 Vaccines above.) 

Persons at increased risk of complications from influenza infection 

Persons aged ≥6 months with conditions predisposing to severe influenza, 7 

such as: 

• Pregnancy – Pregnant women (and women planning pregnancy) are 

recommended to be immunised against influenza because they are at 

increased risk of morbidity and mortality from influenza and because 

there is good evidence that influenza immunisation in pregnancy is safe 

and effective. 38-45 The risk to the mother of complications from influenza 

increases in the later stages of pregnancy. 38-42,46-50 There is also a growing 

body of evidence showing that influenza vaccination of pregnant women 

protects infants against influenza for the first 6 months after birth. 39,51,52 Most 

evidence around infant protection is from studies of maternal influenza 

vaccination in the second or third trimester. 38-42,46-51 Influenza vaccination is 

thought to provide protection for up to a year, but there is limited evidence 

that immunity may start to wane from 4 months following immunisation. 

Although it is recommended that all pregnant women should be immunised 

as early as possible in pregnancy, 53 the precise timing of vaccination will 

depend on the time of the year, vaccine availability, influenza seasonality, 

gestation of pregnancy and the likely duration of immunity. (See also 4.7.8 

Pregnancy and breastfeeding below.) 

• Cardiac disease, including cyanotic congenital heart disease, coronary artery 

disease and congestive heart failure – Influenza causes increased morbidity 

and mortality in children with congenital heart disease and adults with 

coronary artery disease and congestive heart failure. 37,54-57 

• Down syndrome – Persons with Down syndrome should receive annual 

seasonal influenza vaccine whether or not they have congenital heart 

disease. This is due to the presence of anatomical abnormalities, which put 

them at increased risk of upper respiratory tract infections, as well as a high 

prevalence of other medical conditions that put them at increased risk of 

severe influenza. 56 

• Obesity – Persons with significant obesity, defined as a BMI ≥30 kg/m2 , with 

or without other underlying conditions, have been identified as being at 

increased risk for hospitalisation with respiratory complications following 

influenza. 37 This risk was particularly apparent during the 2009–2010 

pandemic. 58,59 


• Chronic respiratory conditions, including: 

» Suppurative lung disease, bronchiectasis and cystic fibrosis37,55 – Patients 

with these diseases are at greatly increased risk from influenza, which may 

cause irreversible deterioration in lung function. 60 

» Chronic obstructive pulmonary disease (COPD) and chronic 

emphysema37,61,62 – Data from several studies provide evidence that 

influenza vaccination has a clinically important protective effect on 

influenza-related COPD exacerbations, and probably an effect on the total 

number of exacerbations in COPD patients. 61,62 

» Severe asthma – In patients with severe asthma, defined as requiring 

frequent hospital visits and the use of multiple medications, annual 

influenza vaccine is an important part of routine care. 37,55 There are 

insufficient data from randomised controlled trials of influenza vaccine 

to define efficacy across the whole spectrum of asthma, but influenza can 

cause severe exacerbations of wheezing, and about 10% of episodes of 

virus-induced wheezing are attributable to influenza. 

• Chronic neurological conditions (e.g. multiple sclerosis, spinal cord injuries, 

seizure disorders or other neuromuscular disorders) – These conditions 

can compromise respiratory function or the expulsion of respiratory 

secretions that can then increase the risk for aspiration. 37,55 Influenza 

vaccination is particularly important for children ≥6 months of age with 

chronic neurological conditions as these children can experience severe, 

even fatal, influenza. 

• Immunocompromising conditions – Persons who are immunocompromised, 

including those with HIV infection, malignancy or chronic steroid 

use, are at an increased risk from influenza (see 3.3,3 Vaccination of 

immunocompromised persons). 37,55 They may also have a reduced immune 

response to the vaccine, although influenza vaccination affords some 

protection. 63 Influenza vaccination is recommended annually in all oncology 

patients aged ≥6 months. 

All immunocompromised persons, irrespective of age, who receive influenza 

vaccine for the first time, are recommended to receive 2 vaccine doses, at 

least 4 weeks apart, and 1 dose annually thereafter. Where it is known that 

a new influenza vaccine strain is circulating in the community to which 

cross-protective immunity in the population is low (such as in the setting of 

an influenza pandemic), it may be appropriate that immunocompromised 

persons receive 2 doses of inactivated influenza vaccine, a minimum of 

4 weeks apart, to achieve an optimal immune response. For example, 

in the 2009–2010 H1N1 global influenza pandemic it was shown that 

seroconversion to influenza vaccination in immunocompromised adolescents 

and adults was improved following receipt of 2 vaccine doses. 64 Further 


4.7 INFLUENZA

information and annual influenza vaccine recommendations are available on 

the Immunise Australia website (www.imunise.health.gov.au). 

While patients with advanced HIV disease and low CD4 + T-lymphocyte 

counts may not develop protective antibody titres, there is evidence that 

for those with minimal symptoms and high CD4 + T-lymphocyte counts, 

protective antibody titres are obtained after influenza vaccination. Influenza 

vaccine has been shown to reduce the incidence of influenza in HIVinfected 

patients, and, although viral load may increase transiently, there 

was no impact on CD4 + count. 63 (See also 3.3 Groups with special vaccination 

requirements, Table 3.3.4.) 

• Other chronic illnesses requiring regular medical follow-up or hospitalisation 

in the preceding year, including: 

» diabetes mellitus37,55,65 » chronic renal failure37,55 » alcoholism66,67 » haemoglobinopathies55 » chronic inherited metabolic diseases (which includes amino acid disorders, 

carbohydrate disorders, cholesterol biosynthesis disorders, fatty acid 

oxidation defects, lactic acidosis, mitochondrial disorders, organic acid 

disorders, urea cycle disorders, vitamin/cofactor disorders, porphyrias) 37,55 

• Long-term aspirin therapy in children (aged 6 months to 10 years) – Such 

children are at increased risk of Reye syndrome after influenza. 68,69 

Aboriginal and Torres Strait Islander people aged ≥15 years 

Annual influenza vaccination is recommended for all Aboriginal and Torres 

Strait Islander people ≥15 years of age, in view of their substantially increased 

risk of hospitalisation and death from influenza and pneumonia. 70 (See also 3.1 

Vaccination for Aboriginal and Torres Strait Islander people and 4.13 Pneumococcal 

disease.) 

Children aged

Residents of residential aged care facilities and long-term residential facilities 

Annual influenza vaccination is recommended for residents of these facilities, 

including inmates of correctional facilities, due to high rates of influenza 

transmission and complications during outbreaks in such facilities. 12,13,62 

Homeless people 

The living conditions and prevalence of underlying medical conditions among 

homeless people will predispose them to complications and transmission of 

influenza. 

Persons who may transmit influenza to persons at increased risk of 

complications from influenza infection 

The following groups of people can potentially transmit influenza to persons 

at increased risk of complications from influenza infection; vaccination of these 

groups is therefore recommended to protect those at risk: 

• all healthcare providers (particularly those of immunocompromised patients) 

• staff (or volunteers) working in nursing homes 

• staff (or volunteers) working in long-term care facilities 

• household contacts (including children ≥6 months of age) of those in highrisk 

groups, including providers of home care to persons at risk of high 

influenza morbidity 

• staff working in early childhood education and care 

• staff (or volunteers) providing care to homeless people. 

Persons involved in the commercial poultry or pork industry or in culling 

poultry or pigs during confirmed avian or swine influenza activity 

Vaccination using the seasonal influenza vaccine composition current at the 

time is recommended for poultry or piggery workers and others in regular close 

contact with poultry or pigs during an avian or swine influenza outbreak. 75 

Although routine seasonal influenza vaccine does not protect against avian or 

swine influenza, there is a possibility that a person who is infected at the same 

time with animal and human strains of influenza virus could act as a vessel for 

reassortment of the two strains to form a virulent strain, with the potential for 

spread from human to human (i.e. initiate a pandemic as was the case with swine 

influenza in 2009). 76 In addition, vaccination can also prevent the transmission of 

influenza from humans to animals. 

Persons providing essential services 

Vaccination of those who provide essential community services will minimise 

disruption of essential activities during influenza outbreaks. Influenza viral 

infections can place considerable pressure upon both public and private 

healthcare services (see 3.3 Groups with special vaccination requirements, Table 

3.3.7 Recommended vaccinations for persons at increased risk of certain occupationally 

acquired vaccine-preventable diseases). 


4.7 INFLUENZA

Workers in other industries 

Due to the high attack rate of influenza in the general population, influenza 

vaccination in the workplace can result in benefits such as increased productivity 

and reduced absenteeism among workers. 77 Employers should consider the 

benefits of offering influenza vaccine in their individual workplace. 

Travellers 

Influenza vaccine is particularly relevant if influenza epidemics are occurring at 

the traveller’s destination(s). Travellers in large tourist groups, especially those 

including older people, those travelling on cruises, and/or those who are likely 

to be in confined circumstances for days to weeks, are at risk of influenza, either 

acquired before departure or from travel to areas of the world where influenza 

is currently circulating. Influenza vaccination is recommended if travelling 

during the influenza season, especially if it is known before travel that influenza 

is circulating in the destination region. 78 (See also 3.2 Vaccination for international 

travel.) 


Influenza vaccination is recommended for pregnant women (see 4.7.7 

Recommendations above) and is safe to administer during any stage of pregnancy 

or while breastfeeding. 44,79-81 




The only absolute contraindications to influenza vaccines are: 

• anaphylaxis following a previous dose of any influenza vaccine 


See 4.7.10 Precautions below for persons with a known egg allergy. 


Persons with known egg allergy82-86 Several recently published reviews, guidelines and reports have indicated that 

the risk of anaphylaxis associated with influenza vaccination of egg-allergic 

patients is very low. 82-86 Persons with egg allergy, including anaphylaxis, can be 

safely vaccinated with influenza vaccines that have less than 1 μg of residual egg 

ovalbumin per dose. 82,84 Due to changes in influenza vaccine manufacturing, the 

majority of influenza vaccines currently used contain less than 1 μg of ovalbumin 

per dose. 82 Note the amount of residual egg ovalbumin may vary from year to 

year due to manufacturing processes, batches and country of origin. 82,84,85 The 

product information (PI) of the vaccine to be given should be checked for the 

vaccine’s ovalbumin content prior to vaccine administration. Allergy testing with 


influenza vaccine prior to administration is not recommended as there is poor 

correlation between test results and vaccine tolerance. 82,84-86 

However, there is still a low risk of anaphylaxis, so it is essential that such 

patients are vaccinated in facilities with staff able to recognise and treat 

anaphylaxis. Additional information on influenza vaccination of individuals 

with an allergy to eggs, including risk, dosage and observation period, can be 

found in the Australasian Society of Clinical Immunology and Allergy (ASCIA) 

guidelines. 84 (See also ‘Vaccination of persons with a known egg allergy’ in 3.3.1 

Vaccination of persons who have had an adverse event following immunisation.) 

Persons with a history of Guillain-Barré syndrome 

Persons with a history of Guillain-Barré syndrome (GBS) have an increased 

likelihood in general of developing GBS again, and the chance of them 

coincidentally developing the syndrome following influenza vaccination may be 

higher than in persons with no history of GBS. 87 Diagnosis of GBS is complex and 

must be made by a physician. (See also 4.7.11 Adverse events below.) 

Children requiring both influenza and 13-valent pneumococcal 

conjugate vaccine 

Parents/carers of infants or children who are recommended to receive both 

influenza vaccine and 13vPCV should be advised of the slightly higher risk 

of fever following concomitant administration of these vaccines (see 4.13 

Pneumococcal disease). Given this relatively low increase in risk, providing 

13vPCV and inactivated trivalent influenza vaccine concurrently to children aged 

12–23 months is acceptable; however, immunisation service providers should 

advise parents regarding this, and provide the option of administering these two 

vaccines on separate days (with an interval of not less than 3 days). In the event 

that fever occurs following either vaccine, an interval may minimise the risk of 

increased adverse reactions. 


Fever, malaise and myalgia occur commonly, in 1 to 10% of persons who receive 

influenza vaccination. 88-90 These adverse events may commence within a few 

hours of vaccination and may last for 1 to 2 days. 88-90 In children

Local adverse events (induration, redness, swelling and pruritus) occur more 

commonly following intradermal influenza vaccine administration. However, 

most patients report that these events are transient and resolve fully within a 

few days. 93 

Post-vaccination symptoms may mimic influenza infection, but all currently 

available influenza vaccines do not contain live virus and so do not cause 

influenza. 

Immediate adverse events (such as hives, angioedema or anaphylaxis) are a 

rare consequence of influenza vaccination. They probably represent an allergic 

response to a residual component of the manufacturing process, most likely egg 

protein. 82,84 Persons with a history of anaphylaxis after eating eggs or a history 

of a severe allergic reaction following occupational exposure to egg protein may 

receive influenza vaccination after medical consultation. 82,84 

A small increased risk of GBS was associated historically with one influenza 

vaccine in the United States in 1976, but, since then, close surveillance has shown 

that GBS has occurred at a very low rate of up to 1 in 1 million doses of influenza 

vaccine, if at all. 94 Diagnosis of GBS is complex and must be made by a physician 

(see ‘Uncommon/rare AEFI’ in 2.3.2 Adverse events following immunisation). 

Narcolepsy (sudden sleeping illness) has been described predominantly in the 

Scandinavian population, in association with adjuvanted pandemic influenza 

vaccines. 95,96 These vaccines were not used and are not available in Australia. 

4.7.12 Public health management of influenza 

Laboratory-confirmed cases of influenza are notifiable in all states and territories 

in Australia. Detailed information regarding the management of influenza cases 

and contacts can be found in the national guidelines for control of influenza97 (www.health.gov.au/cdnasongs). 

Further instructions about the public health management of influenza can also 





The product information for influenza vaccines lists allergy to eggs, chicken 

feathers and/or some food proteins as a contraindication. The ATAGI 

recommends instead that patients with egg allergies and other allergies can 

be vaccinated under strict medical supervision, in accordance with ASCIA 

guidelines. 84 

The product information for Fluvax (CSL Limited) states that this vaccine is 

registered for use in children ≥5 years of age. However, the ATAGI does not 

recommend the use of this vaccine in children aged

4.8 JAPANESE ENCEPHALITIS 


Japanese encephalitis (JE) is caused by a mosquito-borne RNA flavivirus. 


The disease is typically an acute neurological illness, characterised by headache, 

fever, convulsions, focal neurological signs and depressed level of consciousness. 

It has a high case-fatality rate and there is a high prevalence of neurological 

sequelae (up to 50%) in those who survive the acute illness. 1 Less commonly, the 

disease may present as an acute flaccid paralysis. 1 Milder forms include febrile 

illness with headache, and aseptic meningitis. It is recognised, however, that 

most infections are asymptomatic; published estimates of the symptomatic to 

asymptomatic infection ratio vary in different populations from 1:25 to 1:1000. 1 


JE is a significant public health problem in many parts of Asia, including the 

Indian subcontinent, Southeast Asia and China. 1 In recent years, however, the 

disease has extended beyond its traditionally recognised boundaries with, for 

example, occasional cases in eastern Indonesia, occasional outbreaks in the 

Torres Strait and 1 case in north Queensland. 2,3 JE is now considered endemic 

in the Torres Strait region and Papua New Guinea. 2-5 The first ever outbreak of 

Japanese encephalitis (JE) in Australia occurred in the remote outer islands of the 

Torres Strait in 1995, with 3 cases, 2 of them fatal. There have been 5 cases to date 

acquired in Australia. JE virus has only been detected infrequently in sentinel 

animal surveillance in the outer islands. The sentinel pig surveillance system 

has been gradually disbanded since 2006, with surveillance of the last remaining 

herd on Cape York ceasing from the 2011–2012 wet season. 

There has not been a case of JE in the Torres Strait since 1998 and the risk of 

JE has diminished considerably in the outer islands since the mid-1990s. Most 

communities have relocated pigs well away from homes, and major drainage 

works on most islands have markedly reduced potential breeding sites for vector 

mosquitoes. Between 2001 and April 2012, only 4 cases of JE virus infection were 

notified in Australia. 6 

The JE virus is essentially a zoonosis of pigs and wading birds, and is transmitted 

between these animals by culicine mosquitoes. 1 The virus replicates, leading to a 

transient high-level viraemia, within these so-called ‘amplifying’ hosts, but not 

within other large vertebrates such as horses and humans. 

Indeed, humans are an incidental host, infected when living in close proximity 

to the enzootic cycle; this usually occurs in rural areas where there is prolific 

breeding of the vectors in flooded rice fields. 1 

There are two recognised epidemiological patterns of JE. 1 In the temperate or 

subtropical regions of Asia (northern Thailand, northern Vietnam, Korea, Japan, 


4.8 JAPANESE ENCEPHALITIS

Taiwan, China, Nepal and northern India), the disease occurs in epidemics 

during the summer or wet season months (April to May until September to 

October). In the tropical regions (most of Southeast Asia, Sri Lanka, southern 

India), the disease is endemic, occurring throughout the year, but particularly 

during the wet season. 1 A 2006 study confirmed that JE virus is hyperendemic in 

Bali, that it causes substantial human illness, and that it circulates year round. 7 

In some countries (Japan, Taiwan, South Korea and some provinces of China), 

the incidence of JE has declined considerably in recent decades, and it has been 

eradicated from Singapore. Immunisation, changes in pig husbandry, a reduction 

in land utilised for rice farming, and improved socioeconomic circumstances 

have all contributed to these changes. 1 Updated information regarding JE virus 

activity and/or risk in travel destinations should be sought from a reputable 

source prior to travel. 8 


• Imojev – Sanofi Pasteur Pty Ltd (live attenuated Japanese encephalitis 

virus). Lyophilised powder in a monodose vial with separate diluent. 

Each 0.5 mL reconstituted dose contains 4.0–5.8 log plaque-forming 

units (PFU) of live attenuated Japanese encephalitis virus; mannitol; 

lactose; glutamic acid; potassium hydroxide; histidine; human serum 

albumin. No adjuvants or antibiotics are added. 

• JEspect – Intercell Biomedical Ltd/CSL Limited (inactivated Japanese 

encephalitis virus). Each 0.5 mL pre-filled syringe contains 6 μg of 

purified inactivated Japanese encephalitis virus; 0.25 mg aluminium 

as aluminium hydroxide. No preservatives or antibiotics are added. 

Two JE vaccines, each with different characteristics, are available for use 

in Australia. The inactivated mouse brain-derived JE vaccine formulation 

manufactured in Japan, JE-Vax, which was previously used in Australia, is no 

longer manufactured. Clinical and animal studies have provided evidence in 

support of an immunological correlate of immunity (established by the World 

Health Organization as a neutralising antibody titre of ≥1:10). Both currently 

available JE vaccines were registered on the basis of this serological correlate in 

lieu of a field efficacy trial. 

Imojev is a live attenuated, monovalent viral vaccine produced using 

recombinant technology. Two genes of the 17D-204 yellow fever vaccine virus 

have been replaced with two genes, prM and E genes, from the Japanese 

encephalitis virus strain SA 14-14-2. About 94% of healthy adults aged 

18–84 years seroconverted to a strain homologous to that in the Imojev vaccine 

14 days after a single vaccine dose. 9 Several clinical trials have demonstrated that, 


28 days following vaccination with a single dose of Imojev, protective levels of 

neutralising antibodies against the homologous vaccine virus strain are present 

in 96% of vaccine-naïve children aged 12–24 months10 and 99% of adults. 9-12 

Immunogenicity was non-inferior to that attained after a 3-dose primary course 

of the inactivated mouse brain-derived JE vaccine9 that was previously used in 

Australia. Subjects also seroconverted to various wild-type, non-homologous, 

JE virus strains (70 to 97% of children aged 12–24 months and 70 to 100% of 

adults); 10,13 85% of adults developed neutralising antibodies against all four 

wild-type strains used for testing. 12 Protective antibody to the vaccine strain was 

maintained at 6 months after vaccination in 87% of children aged 12–24 months, 10 

and 97% of adults. 12 About 93% of adults maintained a protective antibody level 

to the vaccine strain, and 65% to at least three wild-type strains, 60 months after 

a single vaccine dose. 12 Establishment of immunological memory in vaccinated 

adult subjects has also been demonstrated. 13 

Among children aged 2–5 years previously vaccinated with a mouse brainderived 

JE vaccine (of whom 86% were seropositive against the vaccine strain 

and 72 to 81% seropositive against four wild-type strains at baseline), a dose 

of Imojev produced seroprotective antibody levels against the vaccine strain 

in 100%, and against all wild-type strains in 99%. Ninety-three per cent of the 

children seroconverted to the vaccine strain and 90% against all wild-type 

strains. 10 

JEspect is a Vero cell-derived, inactivated, aluminium-adjuvanted vaccine 

based on the attenuated SA 14-14-2 JE virus strain. JEspect has equivalent 

immunogenicity (after 2 doses, given 4 weeks apart) to 3 doses of the previously 

available mouse brain-derived vaccine, with seroconversion achieved in 98% of 

subjects. 14 Post-vaccination geometric mean titres (GMT) in JEspect recipients 

were significantly higher than GMTs attained after a mouse brain-derived 

vaccine. 14 After a standard 2-dose course, protective levels of neutralising 

antibodies have been found to persist for 6 months in 95%, for 12 months in 83% 

and for 24 months in 48% of JEspect-vaccinated subjects in central Europe, 15,16 

but in 83%, 58% and 48%, respectively, at these three time points in subjects 

in western and northern Europe. 17 A suggested plausible explanation for the 

discrepancy between these two studies is prior vaccination with the tick-borne 

encephalitis vaccine in a large proportion of subjects in the central European 

study. 16,17 In an extension of the western and northern European study, those who 

did not have a seroprotective antibody level at either the 6- or 12-month followup 

point were given a booster dose at 11 and/or 23 months after first vaccination; 

seropositivity was attained in 100% of these subjects. 17 Another study showed 

that a booster dose given 15 months after the primary immunisation with 2 

doses of JEspect increased the GMT by 5-fold after 4 weeks, and the proportion 

of subjects with seroprotective antibody levels increased from 69.2% pre booster 

to 98.5% at 6 and 12 months post booster. Mathematical modelling has predicted 



that 95% of subjects would maintain seroprotective antibodies for 3.8 years after 

a booster dose. 18 

A phase II study in 60 Indian children aged 1 to

When using JEspect in children aged ≥3 years and adults, primary vaccination 

consists of 2 doses, each of 0.5 mL, according to the following schedule: 

• 1st dose at day 0 

• 2nd dose 28 days after the 1st dose. 

Do not mix either Japanese encephalitis vaccine with any other vaccine in the 

same syringe. 


Imojev can be given at the same time as the yellow fever vaccine, 24 using 

separate syringes and separate injection sites. 

Co-administration with other vaccines (including other live vaccines) has not 

been assessed. If Imojev and the yellow fever vaccine or other live vaccines are 

not given simultaneously, they should be given at least 4 weeks apart. 

JEspect can be co-administered with the hepatitis A vaccine. 25 Co-administration 

with other flavivirus vaccines (including yellow fever vaccine) has not been 

assessed. 

If co-administration of either JE vaccine with other vaccines is indicated, 

injections should be given in separate limbs. 


The two available JE vaccines are registered for different age groups, and have 

different vaccination schedules, booster dose requirements, and contraindications 

for use. These factors should be taken into account when deciding the most 

appropriate vaccine to use. 

The dose of Imojev should be administered at least 14 days prior to potential JE 

virus exposure. 

The JEspect vaccine (2-dose) schedule should be completed at least 1 week prior 

to potential JE virus exposure. 

Travellers 

JE vaccination is recommended for: 

• travellers (≥12 months of age) spending 1 month or more in rural areas of 

high-risk countries in Asia and Papua New Guinea (see 4.8.3 Epidemiology 

above); however, as JE has occurred in travellers after shorter periods of 

travel, JE vaccination should be considered for shorter-term travellers, 

particularly if the travel is during the wet season, or anticipated to be 

repeated, and/or there is considerable outdoor activity, and/or the 

accommodation is not mosquito-proof26 • all other travellers spending a year or more in Asia (except Singapore), even 

if much of the stay is in urban areas. 



All travellers to Asia (and other tropical regions) must be fully aware of the need 

to take appropriate measures to avoid mosquito bites. 

The risk of JE to travellers to Asia is determined by the season of travel, the 

regions visited, the duration of travel, the extent of outdoor activity and the 

extent to which mosquito avoidance measures are taken. 1 Clearly the risk is 

greater during prolonged travel to rural areas of Asia during the wet season; it is 

probably negligible during short business trips to urban areas. 

Torres Strait Islands 

JE vaccination is recommended for: 

• all residents (≥12 months of age) of the outer islands in the Torres Strait 

• all non-residents (≥12 months of age) who will be living or working on the 

outer islands of the Torres Strait for a cumulative total of 30 days or more 

during the wet season (December to May). 

Note: The period of greatest risk is from February to March and the vaccination 

course should be completed before February. Those arriving in the outer islands 

late in the wet season (i.e. in May) will arrive after the risk period and do not 

require vaccination. Those visiting the outer islands in the dry season (June to 

November) do not require vaccination. Those visiting only the inner islands, 

including Thursday Island, do not require vaccination. 

Laboratory personnel 

JE vaccination is recommended for all research laboratory personnel who will 

potentially be exposed to the virus. 

Booster doses 

Currently there is limited evidence available to inform recommendations 

regarding the need and appropriate time interval for a booster dose of either 

Imojev or JEspect. 

A booster dose of Imojev is not currently recommended. Preliminary data from 

a subset of participants in a phase II randomised controlled trial demonstrated 

considerable persistence of seroprotective antibody levels 60 months following a 

single dose of Imojev12 (see 4.8.4 Vaccines above). 

Some data suggest that if the primary series of JEspect was administered >1 year 

previously, and there is an ongoing or high risk of JE virus exposure, a booster 

dose should be offered. 16 

For individuals previously vaccinated with the mouse brain-derived JE vaccine, 

either Imojev or JEspect can be used for revaccination if there is an ongoing risk 

of JE virus exposure. 



Imojev is a live attenuated viral vaccine and is contraindicated in pregnant 

women. Pregnancy should be avoided for 28 days after vaccination. 

There are no data on whether the Imojev vaccine virus is excreted in breast milk; 

the vaccine should not be given to breastfeeding women. 

JEspect vaccine is not routinely recommended for pregnant or breastfeeding 

women. However, as JE virus infection during the first and second trimesters 

has been associated with miscarriage, pregnant women at risk of acquiring JE 

should be offered JE vaccination. Although this inactivated JE vaccine might pose 

a theoretical risk to the developing fetus, no adverse outcomes of pregnancy have 

been attributed to vaccination against JE. 

No specific data are available regarding the administration of JEspect to 

breastfeeding women. Breastfeeding women who are at increased risk of 

acquiring JE should be offered JE vaccination. 




JE vaccines are contraindicated in persons who have had: 

• anaphylaxis following a previous dose of any JE vaccine 


Imojev is a live attenuated viral vaccine and must not be administered to 

pregnant or breastfeeding women or to any person who is immunocompromised 

due to either disease and/or medical treatment. 


JE vaccines should not be administered during an acute febrile illness. 

There are few data on the safety and efficacy of JEspect vaccine in persons who 

are immunocompromised. Such persons may not mount an adequate immune 

response, but, as JEspect is an inactivated vaccine, safety and reactogenicity are 

not expected to be of concern in those who are immunocompromised. 


Local reactions and minor systemic reactions are common to very common 

following vaccination against JE. 

In adults, adverse events following Imojev were similar to those in placebo 

recipients, 9,12 but occurred less often than in recipients of the mouse brainderived 

JE vaccine. 9 The most common adverse events in two key studies were 

injection site pain, headache, fatigue and malaise; most symptoms resolved 

within 3 days. 9 Similarly, in children aged 12–24 months, the frequency of 

adverse events after Imojev was comparable to that after the hepatitis A vaccine. 



About 40% of these subjects reported injection site reactions, including pain 

(32%), erythema (23%) and swelling (9%), and about 50% reported at least 

one systemic reaction, including fever (21%), appetite loss (26%), irritability 

(28%) and abnormal crying (23%). Frequencies of adverse events in children 

aged 2–5 years who received Imojev after having been previously vaccinated 

with the mouse brain-derived vaccine were similar to, or lower than, those 

seen in children aged 12–24 months not previously vaccinated. All reactions 

were transient and almost all were mild. Most systemic reactions were mild or 

moderate, appeared within 7 days of vaccination, and lasted up to 3 days. 10 

In a pooled analysis of over 4000 healthy adults who received at least 1 dose 

of JEspect, 54% reported injection site reactions, most commonly pain (33%), 

tenderness (33%) and redness (9%). 27 Headache and myalgia were the most 

commonly reported systemic adverse events. 17,19,27-29 An earlier analysis found a 

comparable rate of adverse events in those who received JEspect compared with 

aluminium-containing placebo. 28 Post-marketing surveillance reported adverse 

events following JEspect at a rate of about 10 per 100 000 doses distributed; 

no serious allergic reactions were observed during the first 12 months after 

marketing approval. 27 The frequencies of adverse events reported following a 

booster dose were similar to those reported after a primary course. 17,18 

4.8.12 Public health management of Japanese encephalitis 

JE virus infection is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of JE, including 

management of cases of JE, should be obtained from state/territory public 


government health authorities and communicable disease control) 


JEspect is registered for use in persons aged ≥18 years. The ATAGI recommends 

that JEspect can be administered to persons aged ≥12 months in circumstances 

where an alternative is not available or contraindicated. The ATAGI also 

recommends that children aged ≥12 months to

4.9 MEASLES 


Measles is a paramyxovirus, genus Morbillivirus. It is an RNA virus with six 

structural proteins, three complexed to the RNA and three associated with the 

viral envelope. Two of the envelope proteins, the F (fusion) protein and the H 

(haemagglutinin) protein, are the most important in pathogenesis. The measles 

virus can survive for up to 2 hours in air, but is rapidly inactivated by heat, light 

and extremes of pH. 1,2 


Measles is a highly infectious, acute viral illness spread by respiratory 

secretions, including aerosol transmission. 1 It is infectious from the beginning 

of the prodromal period and for up to 4 days after the appearance of the rash. 

The incubation period is usually 10 to 14 days. The prodrome, lasting 2 to 4 

days, is characterised by fever and malaise, followed by a cough, coryza and 

conjunctivitis. The maculopapular rash typically begins on the face and upper 

neck, and then becomes generalised. 

Measles is often a severe disease, frequently complicated by otitis media (in 

approximately 9%), pneumonia (in approximately 6%) and diarrhoea (in 

approximately 8%). 1,2 Acute encephalitis occurs in 1 per 1000 cases, and has 

a mortality rate of 10 to 15%, with a high proportion of survivors suffering 

permanent brain damage. 3 Subacute sclerosing panencephalitis (SSPE) is a 

late complication of measles, occurring on average 7 years after infection in 

approximately 0.5 to 1 per 100 000 measles cases. 1 SSPE causes progressive brain 

damage and is always fatal. Complications from measles are more common and 

more severe in the chronically ill, in children 95% 


4.9 MEASLES

for a single dose and >90% for 2 doses required. 9 A decline in vaccination rates 

has resulted in a resurgence in endemic transmission in a number of European 

countries, including the United Kingdom. 10 In 2009, the Australian Childhood 

Immunisation Register recorded that 94.0% of children aged 2 years had received 

at least 1 dose of measles-containing vaccine and 80.3% of children aged 5 years 

had received 2 doses. 11 

National serosurveys in early 1999 (evaluating the 1998 National Measles Control 

Campaign) and in 2000 showed that those most at risk of measles infection 

in Australia were infants


Monovalent measles vaccine is not available in Australia. Measles vaccination 

is provided using either measles-mumps-rubella (MMR) or measles-mumpsrubella-varicella 

(MMRV) vaccines. Two quadrivalent combination vaccines 

containing live attenuated measles, mumps, rubella and varicella viruses 

(MMRV) are registered in Australia. 

Measles immunity induced by 1-dose vaccination provides long-term immunity 

in most recipients. 2,24 However, approximately 5% of recipients fail to develop 

immunity to measles after 1 dose. 25 Following a 2nd vaccine dose, approximately 

99% of subjects overall will be immune to measles. Measles vaccine effectiveness 

studies have found the measles-containing vaccines to be 90 to 95% effective in 

developed country settings with high vaccination coverage and low incidence of 

measles. 2 A Cochrane review reported 1-dose vaccine effectiveness to be 95%; 26 

however, effectiveness has been demonstrated to be lower, particularly by region 

(e.g. Asia, Africa) in 1-dose recipients. 27 

Combination MMRV vaccines have been shown in clinical trials, predominantly 

conducted in children 12 months to 6 years of age, to produce similar rates 

of seroconversion to all four vaccine components compared with MMR and 

monovalent varicella vaccines administered concomitantly at separate injection 

sites. 28-31 In one comparative study assessing seroresponses to a single MMRV 

vaccine dose in 12–14-month-old children, the seroresponse rates to measles, 

mumps and rubella were similar, but varicella seroresponses were lower in 

Priorix-tetra recipients than in ProQuad recipients. 32 However, the clinical 

significance of this is not clear, particularly for MMRV given after MMR vaccine. 32 

Information on adverse events related to MMR and MMRV vaccines is provided 

in 4.9.11 Adverse events below, and also in 4.22 Varicella (for MMRV). 

Trivalent measles-mumps-rubella (MMR) vaccines 

• M-M-R II – CSL Limited/Merck & Co Inc (live attenuated measles 

virus [Enders’ attenuated Edmonston strain], mumps virus [Jeryl 

Lynn B level strain] and rubella virus [Wistar RA 27/3 strain]). 

Lyophilised pellet in a monodose vial with separate diluent. Each 

0.5 mL reconstituted dose contains ≥1000 tissue culture infectious 

dose 50% (TCID ) of Enders’ attenuated Edmonston measles 

50 

virus, ≥12 500 TCID of the Jeryl Lynn B level mumps virus, and 

50 

≥1000 TCID of the Wistar RA 27/3 rubella virus; sorbitol; sucrose; 

50 

hydrolysed gelatin; human albumin; fetal bovine serum; neomycin. 

• Priorix – GlaxoSmithKline (live attenuated measles virus [Schwarz 

strain], mumps virus [RIT 4385 strain, derived from the Jeryl Lynn 

strain] and rubella virus [Wistar RA 27/3 strain]). Lyophilised pellet 


4.9 MEASLES


reconstituted dose contains ≥10 3.0 cell culture infectious dose 50% 

(CCID 50 ) of the Schwarz measles virus, ≥10 3.7 CCID 50 of the RIT 4385 

mumps virus, and ≥10 3.0 CCID 50 of the Wistar RA 27/3 rubella virus; 

lactose; neomycin; sorbitol; mannitol. 

Quadrivalent measles-mumps-rubella-varicella (MMRV) vaccines 

• Priorix-tetra – GlaxoSmithKline (live attenuated measles virus 

[Schwarz strain], mumps virus [RIT 4385 strain, derived from the 

Jeryl Lynn strain], rubella virus [Wistar RA 27/3 strain] and varicellazoster 

virus [Oka strain]). Lyophilised pellet in a monodose vial with 

a pre-filled diluent syringe. Each 0.5 mL reconstituted dose contains 

≥103.0 CCID of the Schwarz measles virus, ≥10 50 4.4 CCID of the RIT 

50 

4385 mumps virus, ≥103.0 CCID of the Wistar RA 27/3 rubella virus, 

50 

and ≥103.3 plaque-forming units (PFU) of Oka varicella-zoster virus; 


• ProQuad – CSL Limited/Merck & Co Inc (live attenuated measles 


Lynn B level strain], rubella virus [Wistar RA 27/3 strain] and 

varicella-zoster virus [Oka/Merck strain]). Lyophilised powder 


reconstituted dose contains ≥10 3.0 TCID 50 of Enders’ attenuated 

Edmonston measles virus, ≥10 4.3 TCID 50 of the Jeryl Lynn B level 

mumps virus, ≥10 3.0 TCID 50 of the Wistar RA 27/3 rubella virus, and 

≥10 3.99 PFU of Oka/Merck varicella virus; sucrose; hydrolysed gelatin; 

urea; sorbitol; monosodium L-glutamate; human albumin; neomycin; 

residual components of MRC-5 cells; bovine serum albumin. 




Both MMR and MMRV vaccines must be reconstituted by adding the entire 

contents of the diluent container to the vial containing the pellet and shaking 

until the pellet is completely dissolved. 

Reconstituted Priorix (MMR), M-M-R II (MMR) and Priorix-tetra (MMRV) 

vaccines should be used as soon as practicable. If storage is necessary, hold at 


Reconstituted ProQuad (MMRV) vaccine must be used within 30 minutes. 



The dose of Priorix (MMR) vaccine for both children and adults is 0.5 mL, to be 

given by either SC or IM injection. 

The dose of M-M-R II (MMR) vaccine for both children and adults is 0.5 mL, to 

be given by SC injection. 

For children

If MMR vaccine is given at

Table 4.9.1: Recommendations for measles vaccination with (a) measlesmumps-rubella 

(MMR) (currently available), and (b) once measlesmumps-rubella-varicella 

(MMRV) vaccines are available from 

July 2013 

Vaccines 

(a) Only monovalent varicella 

vaccine available 

(b) When MMRV vaccine available 

(from July 2013) 

Schedule point (age) 

12 months 18 months 4 years 

MMR VV MMR * 

MMR MMRV – 

* The 2nd dose of MMR-containing vaccine is recommended to be provided at 18 months of age 

to improve 2-dose coverage and protection against measles in young children. However, until 

June 2013, the 2nd dose of MMR vaccine is included under the NIP schedule for administration 

at 4 years of age. From July 2013, the 2nd dose of MMR vaccine will move to the 18-month NIP 

schedule point and be provided as MMRV vaccine. 

Adults and adolescents 

Persons born before 1966 

No vaccination is required for persons born before 1966 (unless serological 

evidence indicates otherwise), as circulating virus and disease were prevalent 

before this time, suggesting most persons would have acquired immunity 

from natural infection. However, confirmed cases of measles have occurred in 

persons born before 19667 and, if doubt exists, it may be more expedient to offer 

vaccination than serological testing. (See also ‘Serological testing for immunity to 

measles’ below.) 

Persons born during or since 1966 

All persons born during or since 1966 who are ≥18 months of age (or, until 

catch-up following the move of the 2nd NIP dose of measles-containing 

vaccine to 18 months of age is completed, are ≥4 years of age) should have 

documented evidence of 2 doses of MMR-containing vaccine (administered 

at least 4 weeks apart and with both doses administered at ≥12 months of age; 

see ‘Children’ above) or have serological evidence of protection for measles, 

mumps and rubella. 

It is recommended that all adolescents and young adults have their 

vaccination records reviewed to ensure they have received 2 doses of MMR 

vaccine (see 4.9.3 Epidemiology above). 

MMRV vaccines are not recommended for use in persons ≥14 years of age, due 

to a lack of data on safety and immunogenicity/efficacy in this age group. If a 

dose of MMRV vaccine is inadvertently given to an older person, this dose does 

not need to be repeated. 


4.9 MEASLES

Healthcare workers and other occupations 

All adolescents and adults (born during or since 1966) should have their 

vaccination records reviewed to ensure they have received 2 doses of MMR 

vaccine. This is important for all persons, but especially those working in certain 

occupations, such as healthcare workers, staff working in early childhood 

education and care, staff of long-term care facilities and staff of correctional 

facilities. Those who were born during or since 1966 and are non-immune, or 

who have only received 1 dose of MMR vaccine, should be vaccinated and have 

documented evidence of 2 doses of MMR vaccine or serological evidence of 

immunity to measles (see ‘Adults and adolescents’ above). (See also 3.3 Groups 

with special vaccination requirements, Table 3.3.7 Recommended vaccinations for 

persons at increased risk of certain occupationally acquired vaccine-preventable diseases.) 

Travellers 

It is especially important that all persons born during or since 1966 have been 

given 2 doses of measles-containing vaccine (administered at least 4 weeks apart, 

with both doses administered at ≥12 months of age; see ‘Children’ above) before 

embarking on international travel if they do not have evidence of previous 

receipt of 2 doses of MMR vaccine or serological evidence of protection for 

measles, mumps and rubella (see ‘Adults and adolescents’ above). 

Infants travelling to countries in which measles is endemic, or where measles 

outbreaks are occurring, may be given MMR vaccine from as young as 9 months 

of age, after an individual risk assessment. In these cases, 2 further doses of 

MMR vaccine are still required. The next dose of MMR vaccine should be given 

at 12 months of age or 4 weeks after the 1st dose, whichever is later. This should 

be followed by the routine administration of the next dose of measles-containing 

vaccine, as MMRV vaccine, at 18 months of age. 

Serological testing for immunity to measles 

Serological testing for immunity to measles, mumps, rubella or varicella is not 

recommended before or after routine administration of the 2-dose childhood 

schedule of these vaccines. 

However, serological testing for measles can be performed in cases where a 

history of natural immunity or 2 doses of vaccine administration is uncertain 

(see ‘Adults and adolescents’ above). Serology is indicated in special situations, 

such as pre-pregnancy planning (see also 4.18 Rubella, 4.22 Varicella and 3.3.2 

Vaccination of women who are planning pregnancy, pregnant or breastfeeding, and 

preterm infants). Serological tests to investigate immunity to measles are generally 

sensitive at detecting antibody produced by both prior natural infection and 

vaccination, although sensitivity varies by assay and the clinical setting (e.g. 

time since vaccination). 2 Interpretation of the results of serological testing may 

be enhanced by discussion with the laboratory that performed the test, ensuring 

that relevant clinical information is provided. An alternative to serological testing 

is presumptive administration of MMR vaccine dose(s). There is no known 


increase in adverse events from vaccinating those with pre-existing immunity to 

one or more of the vaccine components (see 4.9.11 Adverse events below). 


MMR-containing vaccines are contraindicated in pregnant women. Pregnancy 

should be avoided for 28 days after vaccination. 38 

MMR vaccines can be given to breastfeeding women. (See also 4.18 Rubella.) 

MMRV vaccines are not recommended for use in persons aged ≥14 years. 

There is no risk to pregnant women from contact with recently vaccinated 

persons. The vaccine virus is not transmitted from vaccinated persons to 

susceptible contacts. 1 

See also 4.18 Rubella, 4.22 Varicella and 3.3 Groups with special vaccination 

requirements, Table 3.3.1 Recommendations for vaccination in pregnancy for more 

information. 


Anaphylaxis to vaccine components 

MMR and MMRV vaccines are contraindicated in persons who have had: 

• anaphylaxis following a previous dose of any MMR-containing vaccine 



Measles-, mumps- and rubella-containing vaccines contain live 

attenuated vaccine viruses and are contraindicated in persons who are 

immunocompromised. Thus, MMR-containing vaccines are contraindicated in 

the following groups: 

• Persons immunocompromised due to HIV/AIDS. MMR vaccination of 

asymptomatic HIV-infected persons >12 months of age with an age-specific 

CD4 + count of ≥15% may be considered39-42 (see ‘HIV-infected persons’ 

in 3.3.3 Vaccination of immunocompromised persons). Since studies have not 

been performed using combination MMRV vaccines in asymptomatic HIVinfected 

persons or persons with an age-specific CD4 + count of ≥15%, it is 

recommended that only MMR vaccine (and monovalent VV, see 4.22 Varicella) 

be considered for use in this setting. 41,43-45 

• Persons with other medical conditions associated with significant 

immunocompromise (see 3.3.3 Vaccination of immunocompromised persons). 

• Persons receiving high-dose systemic immunosuppressive therapy, 

such as chemotherapy, radiation therapy or oral corticosteroids. MMRcontaining 

vaccines are contraindicated in persons taking high-dose oral 

corticosteroids for more than 1 week (in children equivalent to >2 mg/kg 

per day prednisolone, and in adults >60 mg per day) (see 3.3.3 Vaccination 


4.9 MEASLES

of immunocompromised persons). Those who have been receiving highdose 

systemic steroids for more than 1 week may be vaccinated with live 

attenuated vaccines after corticosteroid therapy has been discontinued 

for at least 1 month46 (see 4.9.10 Precautions below and 3.3.3 Vaccination of 

immunocompromised persons). 

See also 3.3 Groups with special vaccination requirements and 4.22 Varicella for more 

information. 


See 4.9.8 Pregnancy and breastfeeding above. 


Persons with egg allergy 

Children with egg allergy can be safely given MMR or MMRV vaccine. 1,47 Skin 

testing is not required prior to vaccine administration. 1 Although measles and 

mumps (but not rubella or varicella) vaccine viruses are grown in chick embryo 

tissue cultures, it is now recognised that measles- and mumps-containing 

vaccines contain negligible amounts of egg ovalbumin (see 4.9.13 Variations from 

product information below). 

Vaccination with other live attenuated parenteral vaccines 

If MMR or MMRV vaccine is not given simultaneously with other live attenuated 

parenteral vaccines (e.g. varicella, BCG, yellow fever), the vaccines should be 

given at least 4 weeks apart. 

Vaccination after immunoglobulin or blood product administration 

Administration of MMR or MMRV vaccine should be delayed after 

administration of immunoglobulin-containing products. After receipt of 

immunoglobulin-containing blood products, the expected immune response 

to measles, mumps, rubella and varicella vaccination may be impaired. 25,35,48 

MMR-containing vaccines should not be given for between 3 and 11 months 

following the administration of immunoglobulin-containing blood products. 

The interval between receipt of the blood product and vaccination depends on 

the amount of immunoglobulin in each product, and is indicated in 3.3 Groups 

with special vaccination requirements, Table 3.3.6 Recommended intervals between 

either immunoglobulins or blood products and MMR, MMRV or varicella vaccination. 35 

For further information, see 3.3.4 Vaccination of recent recipients of normal human 

immunoglobulin and other blood products. 

Recent blood transfusion with washed red blood cells is not a contraindication to 

MMR or MMRV vaccines. 

MMR vaccine may be administered concomitantly with, or at any time in 

relation to, anti-D immunoglobulin, but at a separate injection site. Anti-D 

immunoglobulin does not interfere with the antibody response to vaccine. 


Immunoglobulin or blood product administration after vaccination 

Immunoglobulin-containing products should not be administered for 3 weeks 

following vaccination with measles-containing vaccines, unless the benefits 

exceed those of vaccination. If immunoglobulin-containing products are 

administered within this interval, the vaccinated person should either be 

revaccinated later at the appropriate time following the product (as indicated in 

Table 3.3.6), or be tested for immunity 6 months later and then revaccinated if 

seronegative. 

Rh (D) immunoglobulin (anti-D) may be given at the same time in different sites 

with separate syringes or at any time in relation to MMR vaccine, as it does not 

interfere with the antibody response to the vaccine. 

HIV-infected persons 

MMR vaccine can be given to asymptomatic HIV-infected persons >12 months 

of age with an age-specific CD4 + count of ≥15% 49 (see 3.3 Groups with special 

vaccination requirements, Table 3.3.4 Categories of immunocompromise in HIV-infected 

persons, based on age-specific CD4 + counts and percentage of total lymphocytes). This is 

because the risk posed by measles infection is considered to be greater than the 

likelihood of adverse events from vaccination. 46 MMR vaccine is contraindicated 

in immunocompromised HIV-infected persons (see 4.9.9 Contraindications above). 

As there are no data available on the safety, immunogenicity or efficacy of MMRV 

vaccines in HIV-infected children, MMRV vaccine should not be administered as 

a substitute for MMR vaccine when vaccinating these children. 25,48 

Persons receiving immunosuppressive therapy 

MMR-containing vaccines may be given to persons on low-dose systemic 

corticosteroid therapy (e.g. children on doses of ≤2 mg/kg per day for less than 

1 week, and those on lower doses of 1 mg/kg per day or alternate-day regimens 

for longer periods). Persons receiving high-dose corticosteroids can receive 

MMR-containing vaccines after corticosteroid therapy has been discontinued 

for at least 1 month (see 4.9.9 Contraindications above). 46 Some experts 

suggest withholding lower doses of steroids 2 to 3 weeks prior to vaccination 

with live viral vaccines, if this is possible. 46,48 (See also 3.3.3 Vaccination of 

immunocompromised persons.) 

Household contacts of persons who are immunocompromised 

Household contacts of persons who are immunocompromised, should ensure 

that they are age-appropriately vaccinated against, or are immune to, measles, 

as well as mumps, rubella and varicella. MMR-containing vaccines can be safely 

administered to household contacts, as measles, mumps and rubella vaccine 

viruses are not transmissible from vaccinated persons to others. 25 If using MMRV 

vaccine, see 4.22 Varicella for information regarding varicella vaccine virus 

transmission. 


4.9 MEASLES

Persons receiving long-term aspirin or salicylate therapy 

There is no need to avoid salicylates before or after MMR or MMRV vaccination. 

Persons receiving long-term salicylate therapy (aspirin) can be vaccinated with 

MMRV, if indicated, as the benefit is likely to outweigh any possible risk of Reye 

syndrome occurring after vaccination with a varicella-containing vaccine (see 

4.22 Varicella). 

Persons with a history of thrombocytopenia 

Thrombocytopenia is a rare adverse event following MMR vaccination (see 

also 4.9.11 Adverse events below). 1,50,51 In children with a past history of an 

episode(s) of idiopathic thrombocytopenia purpura (ITP), the risk of vaccineassociated 

thrombocytopenia occurring following a dose of MMR vaccine has 

been uncertain. 25,51 However, a recent systematic review concluded that MMR 

vaccination, either as a 1st or 2nd dose, did not lead to a recurrence of ITP. 52 

Personal or close family history of seizures or convulsions 

Children with a personal or close family history of seizures or convulsions 

should be given MMR or MMRV vaccine, provided the parents/carers 

understand that there may be a febrile response 5 to 12 days after vaccination. 25 

Advice should be given regarding reducing fever with paracetamol and other 

measures. Due to an increased risk of fever and febrile convulsions in 1st dose 

recipients of MMRV vaccine, MMRV vaccines are only recommended for use as 

the 2nd dose of MMR-containing vaccine (see 4.9.7 Recommendations above and 

4.9.11 Adverse events below). 

Tuberculin skin testing following MMR vaccination 

Measles virus inhibits the response to tuberculin and tuberculin-positive persons 

may become tuberculin-negative for up to a month after measles infection. 25,53 As 

such, tuberculin skin testing (Mantoux test) may be unreliable for at least 4 weeks 

after the administration of measles-containing vaccines. There are no studies 

on the effect of MMR or MMRV vaccination on the results of interferon-gamma 

release assays (IGRAs). 54 


If using MMRV vaccine, additional adverse events relating to the varicella 

vaccine component are outlined in 4.22 Varicella. 

Adverse events following administration of MMR-containing vaccines are 

generally mild and well tolerated. 2 Adverse events are much less common after 

the 2nd dose of MMR or MMRV vaccine than after the 1st dose. 

Fever (with malaise and/or a rash, which is non-infectious) may occur after 

MMR vaccination, most commonly between 7 to 10 days (range 5 to 12 

days) after vaccination and lasting about 2 to 3 days. This coincides with the 

period of peak measles vaccine virus replication. High fever (>39.4°C) occurs 

in approximately 5 to 15% of MMR vaccine recipients, and rash occurs in 


approximately 5%. 2,25 There is also an increased risk for febrile seizures in the 

same time period of approximately 1 case per 3000 doses. 25 

It is recommended that vaccine recipients or their parents/carers be advised 

about possible symptoms, and given advice for reducing fever, including the use 

of paracetamol for fever in the period 5 to 12 days after vaccination. 

Higher rates of fever were observed in clinical trials of both MMRV vaccines, 

particularly following dose 1, when compared with giving MMR vaccine and 

monovalent VV at the same time but at separate sites. 28-31 Two post-marketing 

studies in the United States identified an approximately 2-fold increased risk of 

fever and febrile convulsions in 1st dose recipients of MMRV vaccine, who were 

predominantly 12–23 months of age, in the period 7 to 10 days55 (or 5 to 12 days) 56 

after vaccination, compared with recipients of separate MMR and VV vaccines. 

MMRV vaccination resulted in 1 additional febrile seizure for every 2300 doses 

compared to separate MMR and VV vaccination. 55 An increase in fever or febrile 

convulsions has not been identified after the 2nd dose of MMRV vaccine in the 

United States, although most 2nd dose recipients were aged 4–6 years, an age at 

which the incidence of febrile convulsions is low. 57 These post-marketing studies 

were in children who received ProQuad; however, it is anticipated that this side 

effect profile would be similar in Priorix-tetra recipients. 

A varicelliform rash may occur after MMRV vaccination (see 4.22.11 Adverse 

events in 4.22 Varicella). The appearance of a rash after monovalent varicella 

vaccine occurs in less than 5% of vaccine recipients (usually within 5 to 26 days), 

and similar rates are observed with the use of MMRV vaccine. 58 

Anaphylaxis following the administration of MMR vaccine is very rare (less 

than 1 in 1 million doses distributed). 25 Although no cases of anaphylaxis were 

reported in MMRV vaccine clinical trials, the incidence is likely to be similar to 

that occurring with use of MMR vaccine. Anaphylaxis after vaccination is likely 

due to anaphylactic sensitivity to gelatin or neomycin, not egg allergy (see 4.9.10 

Precautions above). 

Thrombocytopenia (usually self-limiting) has been very rarely associated with the 

rubella or measles component of MMR vaccine, occurring in 3 to 5 per 100 000 

doses of MMR vaccine administered. 1,25,50,51 This is considerably less frequent 

than after natural measles, mumps and rubella infections. 51 Any association with 

MMRV vaccine is expected to be similar. 

It is uncertain whether encephalopathy occurs after measles vaccination. If it 

does, it is at least 1000 times less frequent than as a complication from natural 

infection. 2,25 

Other rare adverse events attributed to MMR vaccine include transient 

lymphadenopathy and arthralgia (see 4.18 Rubella). Parotitis has been reported 

rarely (see 4.11 Mumps). 25 


4.9 MEASLES

Autism, autistic spectrum disorder and inflammatory bowel disease are 

not associated with the MMR vaccine. There has been no credible scientific 

evidence to support this claim and most proponents of the link have retracted 

this claim. 59,60 There is now a substantial body of evidence to refute it61-64 (see 

Appendix 4 Commonly asked questions about vaccination). 

4.9.12 Public health management of measles 

Measles is a notifiable disease in all states and territories in Australia. The public 

health management of measles is described in Measles: national guidelines for public 

health units37 (www.health.gov.au/cdnasongs) and is given urgent public health 

priority. Refer to the national guidelines for current case definitions, testing and 

post-exposure prophylaxis of contacts. 

Further instructions about the public health management of measles can also 




MMR vaccine (and MMRV in some instances) is recommended for post-exposure 

prophylaxis within 72 hours of a non-immune individual being exposed to 

measles. See Table 4.9.2 for detailed information. Administration of normal 

human immunoglobulin (NHIG), rather than MMR or MMRV, is recommended 

in some settings (see Part 5 Passive immunisation and Table 4.9.2). 37 Post-exposure 

prophylaxis should be given on the direction of public health authorities. 

Children >12 months of age who have received 1 dose of measles-containing 

vaccine can be offered their 2nd dose early (if at least 4 weeks after the 1st dose 

has elapsed) if they are considered at risk of coming in contact with measles37 (see 4.9.7 Recommendations above and Table 4.9.2). If varicella vaccination is also 

indicated, MMRV vaccine can be used, although MMRV vaccine is not routinely 

recommended as the 1st dose of MMR-containing vaccine in children aged 

Table 4.9.2: Post-exposure prophylaxis ≤72 hours since exposed to measles 

for non-immune individuals (adapted from Measles: national 

guidelines for public health units) 37 

Age or immune status Measles-mumps-rubella (MMR) vaccination history 

0 doses MMR or 

unknown 

1 dose MMR 2 doses MMR 

Normal human NHIG 

NHIG 

Immunocompromised 

(any age) 

immunoglobulin 

(NHIG) 

0.5 mL/kg to 

maximum of 

15 mL 

0.5 mL/kg to 

maximum of 

15 mL 

0.5 mL/kg to 

maximum of 

15 mL 

NHIG 

0.2 mL/kg 

only if mother 

Not applicable Not applicable 

Birth to 5 months 

has had


The product information for MMR and MMRV vaccines recommends that 

women of child-bearing age should be advised not to become pregnant for 

3 months after vaccination. The ATAGI instead recommends avoiding 

pregnancy for 28 days after vaccination. 38 

The product information for Priorix, M-M-R II, Priorix-tetra and ProQuad states 

that persons with a history of anaphylactic or anaphylactoid reactions to egg 

should not be vaccinated. The ATAGI recommends instead that either Priorix, 

M-M-R II, Priorix-tetra or ProQuad can be given in this situation. 25 

The product information for Priorix-tetra states that it should be given by SC 

injection. The ATAGI recommends that it may also be given by IM injection. 

The product information for ProQuad states that this vaccine is indicated for 

vaccination in individuals 12 months through 12 years of age. The product 

information for Priorix-tetra states that this vaccine can be used in persons from 

9 months of age. The ATAGI recommends instead that both MMRV vaccines 

can be given to persons up to 14 years of age. The ATAGI also recommends that 

MMRV vaccine should not be used routinely as the 1st dose of MMR-containing 

vaccine in children aged

4.10 MENINGOCOCCAL DISEASE 


Meningococcal disease is caused by the bacterium Neisseria meningitidis (or 

meningococcus), a Gram-negative diplococcus. There are 13 known serogroups 

distinguished by differences in surface polysaccharides of the outer membrane 

capsule. Meningococcal serogroups are designated by letters of the alphabet. 

Globally, serogroups A, B, C, W 135 and Y most commonly cause disease. 

Meningococci can be further classified by differences in their outer membrane 

proteins, which are referred to as serotypes and serosubtypes. 1 More recently, 

molecular typing has been used to further differentiate meningococci. There is no 

consistent relationship between serogroup or serotype/subtype and virulence. 2 


N. meningitidis can cause meningitis, septicaemia or a combination of the two. 

Other localised infections, including pneumonia, arthritis and conjunctivitis, 

may also occur but are uncommon. Septicaemia, with or without meningitis, 

can be particularly severe. The overall mortality risk for invasive disease is high 

(between 5 and 10%), despite appropriate antibiotic therapy. 2 Of those who 

survive, approximately 10 to 20% develop permanent sequelae, including limb 

deformity, skin scarring and neurologic deficits. 1 Prior invasive meningococcal 

disease does not induce protective immunity against the implicated serogroup of 

meningococci. Therefore, persons with a history of meningococcal disease should 

still be vaccinated if required. 

N. meningitidis is carried and transmitted only by humans. There are no known 

animal reservoirs. Asymptomatic respiratory tract carriage of meningococci 

is present in about 10% of the population, and the prevalence may be higher 

when groups of people occupy small areas of living space. 3,4 Recent studies 

indicate that there may be a number of factors that contribute to the increased 

risk of contracting meningococcal disease, including exposure to smokers, recent 

illness, living in crowded conditions and multiple intimate kissing partners. 2-4 

Persons with inherited disorders of phagocytosis associated with properdin 

deficiency or absence of the terminal components of complement, as well 

as persons with functional or anatomical asplenia, have an increased risk of 

meningococcal infection. 1 

The disease is transmitted via droplets and has an incubation period of between 

1 and 10 days, but commonly 3 to 4 days. 4 The capacity of meningococcal disease 

to have a fulminant and rapidly fatal course in previously healthy (and usually 

young) persons causes it to be greatly feared. Intensive public health follow-up 

is required after each single case to trace contacts and to institute appropriate 

public health measures for them. As a result of all these factors, this disease can 

cause widespread community alarm and generate significant media interest. 4 


4.10 MENINGOCOCCAL DISEASE


Meningococci cause both sporadic and epidemic disease throughout the world. 

Serogroup A disease occurs predominantly in low-income countries, such as 

those in Africa and Asia, while serogroup B is the major cause of sporadic 

meningococcal disease in most developed countries, including Australia. 

Serogroup C meningococci have been occasionally associated with small 

clusters of meningococcal disease cases in schools, universities and nightclubs in 

Australia in the past. 5-7 Rarely, there are clusters of meningococcal disease cases 

associated with serogroup B. 8 

As in other temperate climates, meningococcal disease cases occurring in 

Australia tend to follow a seasonal trend, with a large proportion of cases 

reported during late winter and early spring. The overall notification rate for 

invasive meningococcal disease to the National Notifiable Diseases Surveillance 

System reached a peak of 3.5 per 100 000 in 2001, but declined to 1 case per 

100 000 in 2010. 9,10 There have been considerable differences noted in the 

incidence of meningococcal disease between Australian states and territories in 

the past. Notifications include meningococcal disease cases that were diagnosed 

on clinical grounds alone, and those cases that were confirmed by laboratory 

methods such as culture, serology or nucleic acid testing of clinical material. 

In 2009, 259 cases were reported nationally, of which 194 were laboratoryconfirmed. 

9,10 The majority of laboratory-confirmed meningococcal cases were 

serogroup B (83%) and serogroup C (5.6%). 10 There has been a sustained decline 

in serogroup C meningococcal disease among the 1–19 years age group, as 

well as other age groups not targeted in the vaccine program, since the 2003 

introduction of routine serogroup C vaccination and catch-up programs. 9-11 In 

other countries that introduced a meningococcal C vaccination program, this 

herd immunity effect has also resulted in a reduction in incidence in age groups 

not targeted by the program. 12-14 

Meningococcal disease can occur in any age group, but a large proportion of 

cases occur in those


There are different types of meningococcal vaccines: 

• meningococcal C conjugate vaccines (MenCCV) 

• Haemophilus influenzae type b–meningococcal C combination vaccine (Hib- 

MenCCV) 

• quadrivalent meningococcal conjugate vaccines (4vMenCV) 

• quadrivalent meningococcal polysaccharide vaccines (4vMenPV). 

Conjugate vaccines 

Meningococcal C conjugate vaccines (MenCCV) 

• Meningitec – Pfizer Australia Pty Ltd (meningococcal serogroup 

C–CRM conjugate). Each 0.5 mL pre-filled syringe contains 10 µg 

197 

Neisseria meningitidis serogroup C oligosaccharide conjugated to 

approximately 15 µg of non-toxic Corynebacterium diphtheriae CRM197 protein; aluminium phosphate. 

• Menjugate Syringe – CSL Limited/Novartis Vaccines and Diagnostics 

Pty Ltd (meningococcal serogroup C–CRM 197 conjugate). Lyophilised 

powder in a monodose vial with a pre-filled diluent syringe. Each 

0.5 mL reconstituted dose contains 10 µg N. meningitidis serogroup C 

oligosaccharide conjugated to 12.5–25 µg of non-toxic C. diphtheriae 

CRM 197 protein; 1.0 mg aluminium hydroxide. 

• NeisVac-C – Baxter Healthcare (meningococcal serogroup C–tetanus 

toxoid conjugate). Each 0.5 mL pre-filled syringe contains 10 µg 

N. meningitidis serogroup C polysaccharide conjugated to 10–20 µg of 

tetanus toxoid; 0.5 mg aluminium as aluminium hydroxide. 

Combination vaccine that contains meningococcal C 

• Menitorix – GlaxoSmithKline (Haemophilus influenzae type b [PRP-T]meningococcal 

serogroup C–tetanus toxoid conjugate). Lyophilised 

powder in a monodose vial with a pre-filled diluent syringe. Each 

0.5 mL reconstituted dose contains 5 µg Hib capsular polysaccharide 

(PRP) conjugated to 12.5 µg tetanus toxoid, and 5 µg N. meningitidis 

serogroup C polysaccharide conjugated to 5 µg tetanus toxoid; traces 

of trometamol and sucrose. 

Quadrivalent meningococcal conjugate vaccines (4vMenCV) 

• Menactra – Sanofi Pasteur Pty Ltd (meningococcal serogroups A, 

C, W , Y–diphtheria toxoid conjugate). Each 0.5 mL monodose vial 

135 



contains 4 µg each of serogroups A, C, W 135 and Y polysaccharides 

conjugated with a total of approximately 48 µg of a diphtheria toxoid 

protein. 

• Menveo – CSL Limited/Novartis Vaccines and Diagnostics Pty 

Ltd (meningococcal serogroups A, C, W 135 , Y–CRM 197 conjugate). 

Lyophilised powder containing serogroup A (MenA) in a monodose 

vial with a pre-filled syringe or vial containing serogroups C, W 135 and 

Y (MenCWY) in saline suspension. Each 0.5 mL reconstituted dose 

contains 10 µg of serogroup A and 5 µg each of serogroups C, W 135 

and Y oligosaccharides individually conjugated with up to 33.3 µg of 

non-toxic C. diphtheriae CRM 197 protein; sucrose. 

All conjugate vaccines induce immunity within 10 to 14 days of administration. 

MenCCVs confer protection only against serogroup C disease. 4vMenCVs will 

provide protection against four serogroups of meningococci: serogroups A, C, 

W and Y. Neither MenCCV nor 4vMenCV will provide protection against 

135 

serogroup B meningococcal disease. 

MenCCVs have been used in an infant schedule in many countries, including 

Australia. 11-13,17-19 The vaccine effectiveness following 1 dose of MenCCV has 

been estimated to range from 83 to 100%. 13,17 There has been a sustained decline 

in serogroup C meningococcal disease, which has also been observed in age 

groups not targeted in vaccination programs, both in Australia and overseas. 11,14 

Duration of immunity is still uncertain. However, current serogroup C 

meningococcal disease epidemiology in Australia suggests ongoing protection in 

those groups previously vaccinated. 11 

Hib-MenCCV can be administered where a booster dose of H. influenzae 

type b and primary vaccination for meningococcal serogroup C is required. 

The immunogenicity and safety of Hib-MenCCV as a booster dose has been 

demonstrated in clinical trials and in the United Kingdom, where this vaccine is 

now administered as part of the infant schedule. 20-25 

Several clinical trials have demonstrated the immunogenicity of 4vMenCV, 

with human serum bactericidal assay titres of ≥1:4 reported in adolescents and 

young adults. 26-28 There have been a number of studies examining 4vMenCV in 

children. 29-31 All studies indicated that 4vMenCVs were safe and immunogenic in 

both infants and children. 29-33 Menveo has demonstrated superiority to Menactra 

in serum bactericidal assays to serogroups A, W and Y (and variably also to 

135 

serogroup C); however, the clinical relevance of this is currently unknown. 27,34-36 


Polysaccharide vaccines 

Quadrivalent meningococcal polysaccharide vaccines (4vMenPV) 

• Mencevax ACWY – GlaxoSmithKline (meningococcal serogroups A, 

C, W 135 and Y polysaccharides). Lyophilised pellet in a monodose vial 

with separate saline diluent. Each 0.5 mL reconstituted dose contains 

50 µg of each meningococcal serogroup polysaccharide; 12.6 mg 

sucrose; 0.1 mg trometamol. 

• Menomune – Sanofi Pasteur Pty Ltd (meningococcal serogroups A, C, 

W 135 and Y polysaccharides). Lyophilised powder in a monodose vial 

with separate saline diluent. Each 0.5 mL reconstituted dose contains 

50 µg of each meningococcal serogroup polysaccharide; 2.5–5 mg 

lactose. 

4vMenPV provides protection against serogroups A, C, W and Y. These 

135 

vaccines induce antibodies in 10 to 14 days in 90% of recipients >2 years of age. 

Immunity decreases markedly during the first 3 years following a single dose of 

vaccine, particularly in infants and young children. However, clinical protection 

persists for at least 3 years in school-aged children and adults. 

The duration of immunity is further complicated by the induction of 

immunological hyporesponsiveness to the serogroup C component 

following repeated vaccination with 4vMenPV, as revaccination results in 

a reduced antibody response compared with the primary immunisation. 37 

This phenomenon has been noted in both children and adults. 38-40 The 

demonstration of subsequent hyporesponsiveness has led to the concern that 

vaccinating persons at low risk may reduce the effectiveness of revaccination 

in a subsequent high-risk situation, although this has not been clinically 

demonstrated. This hyporesponsiveness can be overcome with meningococcal 

conjugate vaccines, 38 although additional doses of a conjugate vaccine may 

be required in young children. There is little response to the serogroup C 

component of the 4vMenPV before 18 months of age and little response to 

serogroup A before 3 months of age. 41 





Menjugate Syringe must be reconstituted by adding the entire contents of the 

diluent syringe to the vial and shaking until the powder is completely dissolved. 

Reconstituted vaccine should be used immediately. 



The product information for NeisVac-C states that this vaccine can be stored at 

+25°C for a period of up to 9 months. Refer to product information for further vaccine 

storage details. 

Menitorix must be reconstituted by adding the entire contents of the diluent 

syringe to the vial and shaking until the powder is completely dissolved. 

Reconstituted vaccine should be used as soon as practicable. If storage is 

necessary, hold at +2°C to +8°C for not more than 24 hours. 

Menveo must be reconstituted by adding the entire contents of the liquid 

MenCWY syringe/vial to the lyophilised MenA vial and shaking until the 

powder is completely dissolved. Reconstituted vaccine should be used as soon 

as practicable. If storage is necessary, hold at +2°C to +8°C for not more than 

24 hours. 


Mencevax ACWY must be reconstituted by adding the entire contents of the 

diluent container to the vial and shaking until the powder is completely 

dissolved. Reconstituted vaccine should be used as soon as practicable. If storage 

is necessary, hold at +2°C to +8°C for not more than 8 hours. 

Menomune must be reconstituted by adding the entire contents of the diluent 

container to the vial and shaking until the powder is completely dissolved. 

Reconstituted vaccine must be used within 24 hours. 



The dose of all meningococcal conjugate vaccines (MenCCV, Hib-MenCCV, 

4vMenCV) is 0.5 mL to be given by IM injection. Do not mix with other vaccines 

in the same syringe. 

MenCCVs are registered for use in infants from 6 weeks of age. Hib-MenCCV 

is registered for use in infants from 6 weeks of age, and can be administered as 

the primary dose of serogroup C meningococcal vaccine and the booster dose 

of Hib vaccine. 

Both 4vMenCVs may be given from 9 months of age (see 4.10.12 Variations 

from product information below). 

Either MenCCV or Hib-MenCCV may be administered simultaneously 

with other vaccines in the NIP schedule (see 4.10.12 Variations from product 

information below). 


The dose of both 4vMenPVs is 0.5 mL, to be given by SC injection. 

4vMenPVs are registered for use in children ≥2 years of age, adolescents and 

adults. 

4vMenPV may also be co-administered with other vaccines. 


Interchangeability of meningococcal vaccines 

Experience from the use of conjugate Hib vaccines suggests that the different 

brands of conjugate meningococcal vaccines are interchangeable. 

There are limited data available on the length of time that should elapse before 

administration of 4vMenCV after giving MenCCV. The ATAGI recommends a 

minimum period of 8 weeks before 4vMenCV is given. 

There are limited data available on the length of time that should elapse 

before administration of either MenCCV or 4vMenCV after giving 4vMenPV. 

A minimum period of 6 months is recommended before conjugate vaccine is 

given. 37,39,40 


Previous meningococcal disease, regardless of the serogroup, is not a 

contraindication to the administration of any meningococcal vaccine. 

Meningococcal C conjugate-containing vaccines 

Children aged 12 months 

It is recommended that a single dose of MenCCV or Hib-MenCCV be given 

to all children at the age of 12 months. 

Hib-MenCCV is administered as a single dose at 12 months of age where a 

booster dose of Hib and the primary dose of serogroup C meningococcal vaccine 

are required. 

Vaccination before 12 months of age is not recommended, except in infants 

with inherited defects of properdin or complement, or functional or anatomical 

asplenia (see ‘Persons at high risk for meningococcal disease’ below). 43,44 Infants, 

other than those described in the circumstances below, who receive dose(s) of 

vaccine at

• Infants from 6 weeks to 12 months of age who have medical conditions 

that put them at high risk of meningococcal disease, such as functional or 

anatomical asplenia43 or inherited defects of properdin or complement, 

persons receiving treatment with eculizumab (a monoclonal antibody 

directed against complement component C5), 45 or those post haematopoietic 

stem cell transplant (HSCT), are recommended to receive up to 2 doses of 

MenCCV vaccine prior to 12 months of age. (See also 3.3 Groups with special 

vaccination requirements.) 

Infants with these conditions who are 6 weeks to

• Children (aged ≥9 months) and adults with high-risk medical conditions, 

such as functional or anatomical asplenia43,44 or complement component 

disorders (C5-C9, properdin, factor D or factor H), persons receiving 

treatment with eculizumab (a monoclonal antibody directed against 

complement component C5), 45 or those post HSCT. In persons with these 

risk factors, a 2-dose primary schedule of 4vMenCV is recommended, with 

doses given approximately 8 weeks apart. 48 Give 4vMenCV at least 8 weeks 

after any previous MenCCV doses. In young children who have received 1 or 

more doses of MenCCV prior to 12 months of age, the 1st dose of 4vMenCV 

is recommended at 12 months of age. The 2nd 4vMenCV dose should be 

provided by 18 months of age. (See also 3.3 Groups with special vaccination 

requirements and Table 3.3.5 Recommendations for vaccination in persons with 

functional or anatomical asplenia.) For persons who have previously received a 

dose of 4vMenPV, a booster dose of 4vMenCV, 3 years after the last dose of 

4vMenPV, is recommended (see ‘Booster doses or revaccination’ below). 

Where 4vMenCV is contraindicated, a single dose of 4vMenPV can be given to 

persons aged ≥2 years, unless otherwise indicated. 

Booster doses or revaccination 

Although the duration of protection following 4vMenCV remains unknown, 

persons with medical conditions that place them at high risk of meningococcal 

disease (as described above) who have completed a 2-dose primary schedule 

of 4vMenCV, should receive 4vMenCV at 5-yearly intervals thereafter, until 

further data becomes available. 36,49,50 This includes high-risk infants who have 

received MenCCV in infancy, followed by 2 doses of 4vMenCV in the 2nd year 

of life. (See also 3.3 Groups with special vaccination requirements and Table 3.3.5 

Recommendations for vaccination in persons with functional or anatomical asplenia.) 

Persons aged ≥9 months with a medical condition that places them at high risk 

of meningococcal disease, and who have previously received 4vMenPV, should 

receive a booster dose of 4vMenCV, 3 years after their last dose of 4vMenPV. 

Thereafter, administer 4vMenCV every 5 years. 

In persons with other risks for meningococcal disease, such as laboratory 

personnel or those travelling to endemic or hyperendemic regions, a dose of 

4vMenCV should be administered every 5 years if the risk of meningococcal 

exposure is ongoing. 

For those aged ≥2 years with underlying risk factors, but in whom 4vMenCV is 

contraindicated, ongoing boosting with 4vMenPV is recommended at 5-yearly 

intervals unless otherwise indicated. 


Meningococcal vaccines are not routinely recommended for pregnant or 

breastfeeding women, 1,51,52 but can be given where clinically indicated (see 4.10.7 







The only absolute contraindications to meningococcal vaccines are: 

• anaphylaxis following a previous dose of any meningococcal vaccine 


Previous meningococcal disease, regardless of the serogroup, is not a 

contraindication to administration of any meningococcal vaccine. 


Common adverse events caused by meningococcal conjugate vaccines are 

pain, redness and swelling at the site of injection, fever, irritability, drowsiness, 

decreased appetite and headaches. 13,21,23-26,29 There are some age-related 

differences in the type of adverse events following vaccination, with systemic 

adverse events tending to decrease with increasing age, and local adverse events 

tending to increase with increasing age. Headache, anorexia, fever and chills 

were more likely to be reported in the adolescent and adult age groups following 

administration of 4vMenCV. 26,29 Among recipients of 4vMenCV, rash and nausea 

were common. However, serious general adverse events are rare. 26,29 

The United States Vaccine Adverse Event Reporting System (VAERS) previously 

reported a series of cases of Guillain-Barré syndrome (GBS) temporally 

associated with the introduction of the 4vMenCV, Menactra. 53,54 The likelihood 

of coincidentally experiencing GBS after administration of 4vMenCV is expected 

to be greater among persons with a history of GBS than among persons with 

no history of GBS. Recent safety studies, during which over 2 million doses of 

Menactra were administered, found there was no risk of GBS after Menactra 

in the general population, and extrapolated these data to conclude that 

persons with a history of GBS are not at higher risk than they are after other 

vaccines that have no association with GBS. 55,56 It is, therefore, recommended 

that 4vMenCV can be administered to persons with previous GBS in whom 

vaccination is indicated. 

Local adverse events after 4vMenPV include erythema, induration, tenderness, 

pain and local axillary lymphadenopathy. However, these reactions are usually 

mild and infrequent. Fever and chills occur in approximately 2% of young 

children, and may persist for 48 hours or longer, but significant general adverse 

events are rare. 

4.10.11 Public health management of meningococcal disease 

Meningococcal disease is notifiable in all states and territories in Australia. 

Further instructions about the public health management of meningococcal 

disease, including management of cases of meningococcal disease and their 

contacts, should be obtained from state/territory public health authorities (see 




If a diagnosis of meningococcal disease is suspected, the patient should be 

immediately given parenteral (usually IM) penicillin and transferred to hospital. 

A potential outbreak of meningococcal disease in an institutional or community 

setting is a public health emergency needing a rapid response from clinicians 

and public health practitioners. The decision to control an outbreak with a 

vaccination program should be made by the appropriate Public Health Unit, 

following the Guidelines for the early clinical and public health management of 

meningococcal disease in Australia. 2 


The product information for meningococcal C conjugate vaccines states that, 

under the age of 12 months, either 2 (NeisVac-C) or 3 (Meningitec and Menjugate 

Syringe) doses of vaccine are required. The ATAGI recommends instead that 

meningococcal C vaccination is routinely not recommended before 12 months of 

age (unless specifically indicated). 

The product information for Meningitec states that an allergic reaction following 

a previous dose is a contraindication to further doses. The ATAGI recommends 



The product information for NeisVac-C states that the vaccine should not be 

administered with pneumococcal conjugate vaccine, hepatitis B vaccine or 

PRP-OMP Haemophilus influenzae type b vaccine unless ‘medically important’. 

The ATAGI recommends instead that the vaccine may be administered 

simultaneously with other vaccines in the NIP. There have been publications 

citing the co-administration of MenCCV with other combination vaccines and it 

was found to be immunogenic and safe. 57,58 

The product information for Menactra states that a previous episode of Guillain- 

Barré syndrome is a contraindication to vaccination with Menactra. The ATAGI 

recommends instead that either of the available 4vMenCVs can be administered. 

The product information for Menactra states that this vaccine is indicated for use 

in persons aged 2–55 years. The ATAGI recommends instead that Menactra can 

be given to persons aged ≥9 months of age. 

The product information for Menveo states that this vaccine is indicated for use 

in persons ≥11 years of age. The ATAGI recommends instead that Menveo can be 

given to persons aged ≥9 months of age. 

The product information for all meningococcal vaccines (MenCCV, 4vMenCV 

and 4vMenPV) states that there are no data on the use of these vaccines in 

lactating women. The ATAGI recommends that breastfeeding women can be 

vaccinated. 



The product information for both 4vMenCVs states that vaccine should be 

administered as a single dose. The ATAGI recommends that these vaccines can be 

given in a 2-dose primary schedule to children (aged ≥9 months) and adults with 

high-risk medical conditions. 

The product information for both 4vMenCVs states that the need for, or timing 

of, booster doses has not yet been determined. The ATAGI recommends that, 

until more data become available, individuals with underlying risk factors, 

including functional or anatomical asplenia, should continue to receive 

4vMenCV at 5-yearly intervals. 

References 




4.11 MUMPS 


Mumps is a paramyxovirus, genus Rubulavirus, with a single-stranded RNA 

genome. It is rapidly inactivated by heat, formalin, ether, chloroform and light. 1 


Mumps is an acute viral illness with an incubation period of 12 to 25 days. 2 

Transmission is via respiratory secretions, including aerosol transmission, or by 

direct contact with saliva or possibly urine. 2 Asymptomatic infection occurs in 

one-third of cases. 3 Symptomatic disease ranges from mild upper respiratory 

symptoms to widespread systemic involvement. 3 A high proportion of mumps 

infections involve non-specific symptoms including fever, headache, malaise, 

myalgia and anorexia. 4 The characteristic bilateral, or occasionally unilateral, 

parotid swelling occurs in 60 to 70% of clinical cases. 4,5 Maximum infectiousness 

occurs between 2 days before onset of illness and 4 days afterwards, but patients 

may be infectious from 7 days before parotid swelling to 9 days after. 2 Meningeal 

symptoms and signs appear in approximately 10% of cases, but permanent 

neurologic sequelae are rare. 2 Mumps encephalitis has been estimated to occur 

in 1–2 per 10 000 cases, with a case-fatality rate of around 1.0%. 6 Deafness is 

relatively common in mumps meningoencephalitis, although permanent nerve 

deafness is rare (1 in 20 000 infections). Orchitis (usually unilateral) has been 

reported in up to 15 to 30% of clinical mumps cases in post-pubertal males, 

but subsequent sterility is rare. 6 Symptomatic involvement of other glands and 

organs has been observed less frequently (pancreatitis, oophoritis, hepatitis, 

myocarditis, thyroiditis, mastitis). 1,4 

Mumps infection during the first trimester of pregnancy may result in 

spontaneous abortion. 3,4 Maternal infection is not associated with an increased 

risk of congenital malformation. 3,4 


Mumps is reported worldwide. Prior to universal vaccination, mumps was 

primarily a disease of childhood with the peak incidence in the 5–9 years 

age group. However, since 2000, peak rates have been reported in older 

adolescents and young adults, especially the 20–34 years age group. 7-10 

Between 2002 and 2004, mumps notifications were the lowest recorded in 

Australia, averaging 0.4 per 100 000. 11 In 2005, notifications increased to 

1.2 per 100 000, peaking at 2.7 per 100 000 in 2007, but have since declined to 

less than 1 per 100 000 since 2009. 10,11 There have also been recent outbreaks of 

mumps in the United States and Europe, where the peak rates of disease have 

been in the 18–24 years age group. 12-15 


4.11 MUMPS

Similar to measles, persons born in the late 1960s to mid-1980s (especially the 

1978–1982 birth cohort) are recognised to be at a greater risk of mumps. Many 

missed being vaccinated or acquiring mumps infection as infants (when vaccine 

coverage was low and disease incidence was decreasing), and may also have 

missed catch-up vaccinations during their school years as part of either the 

Measles Control Campaign (which only targeted primary-school-aged children) 

or the Young Adult Measles Control Campaign (which did not result in high 

coverage). 16,17 During outbreaks, mumps attack rates are lowest in persons who 

have received 2 doses of mumps-containing vaccines, as this provides optimal 

long-term protection. 5,13 In Australia, over the 11-year period from 1996 to 2006, 

mumps was reported as the underlying cause of 5 deaths, all in adults aged over 

80 years. 7-10 


Monovalent mumps vaccine is not available in Australia. Mumps vaccination 

is provided using either measles-mumps-rubella (MMR) or measles-mumpsrubella-varicella 

(MMRV) vaccines. Two quadrivalent combination vaccines 

containing live attenuated measles, mumps, rubella and varicella viruses 

(MMRV) are registered in Australia. 

Clinical trials of MMR vaccine indicate 95% mumps seroconversion after a single 

dose and up to 100% after a 2nd dose. 4 However, outbreak investigations and 

post-marketing studies have reported 1-dose vaccine effectiveness to be between 

60 and 90%. 13,18 A Cochrane review reported 1-dose vaccine effectiveness to be 

between 69% and 81% for the vaccine containing the Jeryl Lynn mumps strain 

and between 70% and 75% for the vaccine containing the Urabe strain. 19 While 

protection is greater in 2-dose vaccine recipients, recent outbreaks have reported 

mumps in 2-dose vaccine recipients, particularly young adults who received 

their vaccines more than 10 years previously. 14,15,20,21 

Combination MMRV vaccines have been shown, in clinical trials, to produce 

similar rates of seroconversion to all four vaccine components compared with 

MMR vaccine and monovalent varicella vaccines administered concomitantly at 

separate injection sites. 22-25 

See further information on MMR and MMRV vaccines in 4.9 Measles and 

4.22 Varicella. 


Trivalent measles–mumps–rubella (MMR) vaccines 






dose 50% (TCID 50 ) of Enders’ attenuated Edmonston measles 

virus, ≥12 500 TCID 50 of the Jeryl Lynn B level mumps virus, and 

≥1000 TCID 50 of the Wistar RA 27/3 rubella virus; sorbitol; sucrose; 
















≥103.0 CCID of the Schwarz measles virus, ≥10 50 4.4 CCID of the RIT 

50 

4385 mumps virus, ≥103.0 CCID of the Wistar RA 27/3 rubella virus, 

50 

and ≥103.3 plaque-forming units (PFU) of Oka varicella-zoster virus; 







reconstituted dose contains ≥103.0 TCID of Enders’ attenuated 

50 

Edmonston measles virus, ≥104.3 TCID of the Jeryl Lynn B level 

50 

mumps virus, ≥103.0 TCID of the Wistar RA 27/3 rubella virus, and 

50 

≥103.99 PFU of Oka/Merck varicella virus; sucrose; hydrolysed gelatin; 




4.11 MUMPS












The dose of Priorix (MMR) vaccine for both children and adults is 0.5 mL to be 


The dose of M-M-R II (MMR) vaccine for both children and adults is 0.5 mL to be 

given by SC injection. 

For children


Infants aged

MMRV vaccines are not recommended for use in persons ≥14 years of age, due to 

a lack of data on safety and immunogenicity/efficacy in this age group. If a dose 

of MMRV vaccine is inadvertently given to an older person, this dose does not 

need to be repeated. 

For further information on the recommendations for MMR and MMRV vaccines, 

see 4.9 Measles and 4.22 Varicella. 

Serological testing for immunity to mumps 

Serological testing for immunity to mumps (and measles, rubella and varicella) is 

not recommended before or after routine administration of the 2-dose childhood 

schedule of these vaccines. 

However, serological testing for mumps (and measles and rubella) can be 

performed in cases where a history of natural immunity or 2 doses of vaccine 

administration is uncertain (see ‘Adults and adolescents’ above). Serology is 

indicated in special situations, such as pre-pregnancy planning (see also 4.9 

Measles, 4.18 Rubella and 4.22 Varicella). Serological tests to investigate immunity 

to mumps are generally sensitive at detecting antibody produced by both prior 

natural infection and vaccination, although sensitivity varies by assay and 

the clinical setting (e.g. time since vaccination). 4 Interpretation of the results 

of serological testing may be enhanced by discussion with the laboratory that 

performed the test, ensuring that relevant clinical information is provided. An 

alternative to serological testing is presumptive administration of MMR vaccine 

dose(s). There is no known increase in adverse events from vaccinating those 

with pre-existing immunity to one or more of the vaccine components (see 4.11.11 

Adverse events below). 


MMR-containing vaccines are contraindicated in pregnant women. Pregnancy 

should be avoided for 28 days after vaccination. 29 

MMR vaccines can be given to breastfeeding women. (See also 4.18 Rubella.) 


See also 4.9 Measles, 4.18 Rubella, 4.22 Varicella and 3.3 Groups with special 

vaccination requirements, Table 3.3.1 Recommendations for vaccination in pregnancy 

for more information. 


For information on contraindications to MMR and MMRV vaccines, see 4.9 

Measles and 4.22 Varicella. 


For additional precautions related to MMR and MMRV vaccines, see 4.9 Measles 

and 4.22 Varicella. 










The most common adverse events following mumps vaccination are fever and 

parotitis. 4 Parotitis occurs most commonly from 10 to 14 days after vaccination. 

The incidence varies by vaccine strain; in studies of the Jeryl Lynn vaccine strain, 

parotid and/or submandibular swelling occurred in 0.5 to 1.6% of recipients. 4,30,31 

An increased risk of aseptic meningitis has been observed after vaccination with 

the Urabe strain of mumps vaccine in some countries. 4 However, the Urabe strain 

is not used in Australia. MMR and MMRV vaccines available in Australia contain 

a Jeryl Lynn-derived strain of mumps, which is not associated with an increased 

risk of aseptic meningitis. 32,33 

For further information on the adverse events associated with MMR and MMRV 

vaccines, see 4.9 Measles and 4.22 Varicella. 

4.11.12 Public health management of mumps 

Mumps is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of mumps, including 

management of cases of mumps and their contacts, should be obtained from 

state/territory public health authorities (see Appendix 1 Contact details for 

Australian, state and territory government health authorities and communicable 


Mumps-containing vaccine does not provide protection if given after an 

individual has been exposed to mumps. 1,34 However, if the exposure did not 

result in infection, the vaccine would induce protection against subsequent 

infection. Normal human immunoglobulin (NHIG) has been shown not to be of 

value in post-exposure prophylaxis for mumps. 1,34 


For information on MMR and MMRV vaccines, see 4.9 Measles and 4.22 Varicella. 

References 




4.11 MUMPS

4.12 PERTUSSIS 


Pertussis (whooping cough) is caused by Bordetella pertussis, a fastidious, Gramnegative, 

pleomorphic bacillus. There are other organisms (such as Bordetella 

parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae) that can cause a 

pertussis-like syndrome. 1 


Pertussis is a respiratory infection with an incubation period of 7 to 20 days. In 

unvaccinated persons, B. pertussis is highly infectious, spreading by aerosols 

to 90% of susceptible household contacts. 2 Natural infection does not provide 

long-term protection and repeat infection can occur. 2 The characteristic 

paroxysmal cough with inspiratory whoop seen in unvaccinated children is less 

common in individuals who have varying degrees of immunity acquired from 

vaccination or infection. 3 It has been estimated that B. pertussis accounts for up 

to 7% of cough illnesses per year in adults and, each year, more than 25% of 

adults experience a coughing illness of at least 5 days duration. 4 Even in adults, 

pertussis can be associated with significant morbidity, with cough persisting for 

up to 3 months, and other significant symptoms, such as sleep disturbance or, 

rarely, rib fracture. 5 Identification of pertussis is limited by patient and physician 

awareness and, in some cases, the limited sensitivity of diagnostic tests; it is 

generally believed to be significantly under-diagnosed (see 4.12.11 Public health 

management of pertussis below). 

Death due to pertussis is rare in people aged 10–70 years. However, the casefatality 

rate in unvaccinated infants

acquired from healthcare workers. 15-18 Pertussis hospitalisation rates for persons 

aged ≥60 years are higher than for other adults. 19 

Between 2000 and 2010, multiple epidemics of pertussis occurred in Australia; 

however, the timing and frequency of these varied by geographical location. 

More than 139 000 cases were reported over this 11-year period, with the 

highest annual incidence of notifications (156 cases per 100 000 population) 

reported in 2010. 20 

There have been a number of changes introduced to the NIP schedule over 

time in an attempt to improve control of pertussis. Introduction of a 5th dose of 

diphtheria, tetanus and whole-cell pertussis vaccine (DTPw) for 4–5-year-old 

children in August 1994 was followed by a decrease in notifications consistent 

with a vaccine effect; first among children aged 5 and 6 years, then by those 

in the 7–9 years age group. 8,21 Subsequently, the average age of pertussis 

notifications continued to increase. By 2005, the proportion of notifications in 

adults >20 years of age had reached 83%, 8 compared with 40% in the early 1990s. 

Acellular pertussis vaccine (DTPa) replaced DTPw for booster doses in 1997, 

and for all doses from 1999. In 2003, the DTPa booster dose at 18 months of age 

was removed from the NIP, moving the 1st booster dose to 4 years of age. The 

removal of the 18-month booster dose from the schedule was based on evidence 

from an Italian longitudinal study of DTPa trial participants. The study found 

that a primary DTPa course at 2, 4 and 6 months of age provided 76 to 80% 

protection from prolonged cough disease and this was maintained until 6 years 

of age. 22 

In 2009–2010, in contrast to previous epidemics, the highest notification rates 

in Australia were in children 20 years of age decreased to 57%. The greatest increase in notification 

rate occurred in 3-year-old children. Although increased and more sensitive 

diagnostic testing using polymerase chain reaction (PCR) has contributed to 

this rise, vaccine effectiveness among 3-year olds has been estimated at around 

60%, 23 consistent with waning of immunity following the primary DTPa course. 

In contrast to notifications, hospitalisation and death rates from pertussis in 

the most recent epidemic periods have not increased substantially. 24 A high 

proportion of hospitalisations, and almost all deaths, attributed to pertussis 

occur in infants too young to have received more than 1 dose of pertussiscontaining 

vaccine. 19,25 

The prevention of severe pertussis morbidity and deaths, particularly in infants 

Pregnancy and breastfeeding below). Data to evaluate the effectiveness of indirect 

protection to infants from the cocoon approach are lacking. 28 However, this 

approach is expected to reduce infection risk to infants from family members, 

known to be an important source of pertussis infection, 13,14 especially for the 

youngest infants. 11,12 


Pertussis vaccine is available in Australia only in combination with diphtheria, 

tetanus and other antigens. 






Acellular pertussis-containing vaccines have been used for both primary and 

booster vaccination of children in Australia since 1999. Whole-cell pertussiscontaining 

vaccines were used exclusively before 1997. Between 1997 and 1999 

acellular vaccines were used for booster doses. There are a number of acellular 

pertussis-containing vaccines that contain three or more purified components 

of B. pertussis. In the 3-component vaccines, these components are pertussis 

toxin (PT), filamentous haemagglutinin (FHA) and pertactin (PRN). In the 

5-component vaccines, fimbrial (FIM) antigens are also included. 

Pertussis vaccines provide good protection against severe and typical pertussis, 

but substantially less against milder coughing illness. 29,30 Vaccine efficacy of 

DTPa vaccines with three or more antigens has been reported as 71 to 78% 

for preventing milder symptoms of pertussis and 84% for preventing typical 

disease. 30 Epidemiological data suggest that receipt of the 1st dose of the 

primary DTPa course significantly reduces the incidence of severe pertussis 

disease in young infants, as measured by hospitalisation rates. 31-33 Data on the 

duration of immunity following DTPa vaccine indicate that waning occurs 5 to 

6 years after the last dose of vaccine. 2,34 However, these studies could not control 

for levels of circulating pertussis in the population, which may boost the level 

of immunity and lead to over-estimation of the duration of protection against 

symptomatic disease. 29,30 

Reduced antigen content formulation, dTpa, vaccines are immunogenic. 35-38 

A randomised trial in adults reported a point estimate of 92% efficacy against 

culture/nucleic acid test-positive disease within 2.5 years of vaccination 

with a 3-component monovalent pertussis vaccine. 4 Data on the duration of 

immunity to pertussis following a single booster dose of dTpa are limited. Longterm 

follow-up of adults vaccinated with dTpa has shown a rapid decline in 

levels of pertussis antibodies within the first 2 years after vaccination, with a 

continued steady decline out to 10 years after vaccination, although antibody 

levels remained above baseline. 39 A similar long-term follow-up of adolescents 


demonstrated a more rapid decline, with pertussis antibody levels decreasing 

to or approaching pre-vaccination levels after 10 years. 40 The rate of decline 

in clinical protection is unknown, but some protection against clinical disease 

is likely to persist for up to 10 years. Recent studies have indicated that dTpa 

vaccine is immunogenic in the elderly. 38 

Vaccines containing DTPa are available in various combinations with inactivated 

poliomyelitis, hepatitis B and Haemophilus influenzae type b vaccines. 

Formulations for children aged











neomycin. 





Reduced antigen formulations for adults, adolescents and children 

aged ≥10 years 





















glycine. 


















The dose of all pertussis-containing vaccines is 0.5 mL to be given by IM 

injection. 

Do not mix DTPa- or dTpa-containing vaccines with any other vaccine in the 

same syringe, unless specifically registered for use in this way. 



Pertussis-containing vaccine is recommended in a 3-dose primary schedule for 

infants at 2, 4 and 6 months of age. Due to the high morbidity and occasional 

mortality associated with pertussis in the first few months of life, the 1st dose can 

be given as early as 6 weeks of age (see Table 2.1.5 Minimum acceptable age for the 

1st dose of scheduled vaccines in infants in special circumstances). Giving a 1st dose at 

6 weeks of age rather than 2 months of age is estimated to prevent an additional 

8% of infant pertussis cases. The next scheduled doses should still be given at 

4 months and 6 months of age. 31,42 

A booster dose of pertussis-containing vaccine, usually provided as DTPa-IPV, 

is recommended at 4 years of age, but can be given as early as 3.5 years of age. 

This booster dose is essential as waning of pertussis immunity occurs following 

receipt of the primary schedule. 2,34 For this booster dose, all brands of DTPacontaining 

vaccines are considered interchangeable. 


4.12 PERTUSSIS



in the previous 10 years. 19,45 Adults of all ages who require a booster dose of dT 

vaccine should be encouraged to do so with dTpa vaccine, particularly if they 

have not received a dTpa dose previously (see 4.19 Tetanus and 4.2 Diphtheria). 46 

Travellers should receive a booster dose of dT (or dTpa if not given previously) 

if more than 10 years have elapsed since the last dose of dT-containing vaccine. 



of a dT-containing vaccine (see 4.19 Tetanus and 4.2 Diphtheria). 

For those adults requiring additional protection from polio (see 4.14 Poliomyelitis), 

dTpa-IPV can be used. 


or pertussis-containing vaccine requiring catch-up, see 4.19 Tetanus and 2.1.5 

Catch-up. 

Persons in contact with infants and others at increased risk from pertussis 

There is significant morbidity associated with pertussis infection in infants 

Healthcare workers 

All healthcare workers should receive dTpa vaccine because of the significant 

risk of nosocomial transmission of pertussis to vulnerable patients. 15-18 (See 

also 3.3 Groups with special vaccination requirements, Table 3.3.7 Recommended 


diseases.) A booster dose of dTpa is recommended if 10 years have 

elapsed since a previous dose. 39,40 Vaccinated healthcare workers who develop 

symptoms compatible with pertussis should still be investigated for pertussis. 

There have been cases of nosocomial transmission of pertussis to infants from 

healthcare workers who have previously received dTpa vaccine. 17 

Staff working in early childhood education and care 

Adults working with infants and young children aged

(see ‘Women who are planning pregnancy, pregnant or post-partum’ in 4.12.7 


Recently, it has been recommended in the United States, the United Kingdom and 

New Zealand that dTpa vaccine administered in the last trimester of pregnancy 

be preferred to post-partum maternal immunisation, for various reasons, 

including difficulties in implementation of the latter strategy, theoretical reasons 

why vaccination during pregnancy might be more effective, and the favourable 

safety profile of maternal vaccination. 53 Theoretical reasons for effectiveness are: 

1) that administration of dTpa during the third trimester of pregnancy results in 

high maternal pertussis antibody levels and transplacental transfer of antibodies 

to the infant; 54,55 and 2) that the levels of pertussis antibodies measured in cord 

blood in such infants are similar to those observed in infants at 12 months of age 

following a 3-dose DTPa course. 56 This is likely to provide protection against 

pertussis in the 1st month of an infant’s life, prior to commencement of the 

primary DTPa schedule. In addition, a woman vaccinated with dTpa during 

pregnancy will herself be protected against pertussis during the third trimester 

and will be less likely to transmit pertussis to the infant after delivery. Although 

specific safety data are limited, dTpa is an inactivated vaccine and there is 

evidence for the safety of this and other inactivated vaccines, such as tetanus and 

influenza, in pregnancy. 53,57 Safety of dTpa vaccines in pregnancy was not studied 

specifically during pre-market evaluations, but review of the available data from 

pregnancy registries, small studies and the United States Vaccine Adverse Event 

Reporting System did not indicate a higher frequency or unusual pattern of 

adverse events in pregnant women who received dTpa. 53 

A potential disadvantage of giving dTpa in the third trimester of pregnancy 

is that maternal pertussis antibodies may interfere with an infant’s immune 

response following the primary 3-dose DTPa course at 2, 4 and 6 months of age, 53 

a phenomenon referred to as ‘blunting’. 27,53,58 However, because correlates of 

protection are not fully understood, the clinical importance of this is uncertain. 

Although severe morbidity and mortality from pertussis is rare after 6 months of 

age, it is possible that a reduced immune response to the infant’s primary course 

of DTPa-containing vaccine could result in less protection against pertussis in the 

2nd year of life. This provides the rationale for provision of an additional booster 

dose of a pertussis-containing vaccine (DTPa) in the 2nd year of life to children 

born to mothers who received dTpa during pregnancy (see ‘Infants and children’ 

in 4.12.7 Recommendations above). 




4.12 PERTUSSIS


The only absolute contraindications to acellular pertussis-containing 

vaccines are: 

• anaphylaxis following a previous dose of any acellular 

pertussis-containing vaccine 



Acellular pertussis vaccines are associated with a much lower incidence of fever 

(approximately 20%) and local adverse events (approximately 10%) than wholecell 

pertussis vaccines (approximately 45% and 40%, respectively), which are no 

longer used in Australia. 29,30,59 The reduced antigen content dTpa vaccines are safe 

and well tolerated in adults. 35,60,61 The incidence of fever is low, and comparable 

in vaccinated and placebo trial participants. 35,60,61 Booster doses of dTpa within 

10 years are also safe and well tolerated in adults. Limb swelling reactions from 

booster doses are rare. 39,40,52 

Extensive limb swelling, defined as swelling and/or redness involving at least 

half the circumference of the limb and the joints both above and below the 

injection site, is a recognised adverse event that occurs rarely following booster 

doses of DTPa. Such reactions commence within 48 hours of vaccination, last 

for 1 to 7 days and resolve completely without sequelae. 43 The pathogenesis of 

extensive limb swelling is poorly understood. In an analysis of 4th and 5th dose 

follow-up studies that examined 12 different DTPa vaccines, 2% of 1015 children 

who received consecutive doses of the same DTPa vaccine reported entire thigh 

swelling, which resolved completely. 43 A history of extensive limb swelling after 

a booster dose of DTPa is not a contraindication to reduced antigen formulations 

of dTpa at 11–13 years of age (or older). 62 Parents of children about to receive 

the booster dose of a DTPa-containing vaccine (at 4 years of age) should be 

informed of the small but well-defined risk of this adverse event which, even 

when extensive, is usually not associated with significant pain or limitation of 

movement. 

Febrile convulsions are very infrequently reported following DTPa-containing 

vaccines, within 48 hours of vaccination. The risk is even lower in infants who 

complete their primary course at 6 months of age, as febrile convulsions are 

uncommon in children

an HHE. An HHE may last from a few minutes to 36 hours. In Australia during 

2009, 3.2 cases of HHE were reported per 100 000 doses of DTPa-containing 

vaccine given to children

To reduce the risk of transmission of B. pertussis, persons with pertussis infection 

should commence appropriate antibiotic therapy on clinical suspicion, if within 

21 days of the onset of coryza. Antibiotic treatment does not shorten the course 

of the illness, but reduces infectivity if provided early in the illness. Detailed 

information regarding appropriate macrolide antibiotics and dosing can be found 

in the national guidelines for control of pertussis. 72,74 

Management of contacts of cases 

Vaccination 

Since a primary vaccination course requires three or more injections to protect 

against pertussis, infant vaccination cannot be effectively used to protect 

unimmunised infants. Vaccination has not been shown to have a role in 

controlling outbreaks at any age, even in closed settings. However, unvaccinated 

or partially vaccinated contacts, up to their 10th birthday, should be offered 

DTPa-containing vaccines, and older contacts should be offered dTpa (see 2.1.5 

Catch-up). 

Passive immunisation with normal human immunoglobulin is not effective in the 

prevention of pertussis. 

Chemoprophylaxis 

The benefit of chemoprophylaxis in preventing the secondary transmission 

of pertussis is limited due to multiple factors, including delayed clinical 

presentation, delayed diagnosis and imperfect compliance. 75 The use of 

chemoprophylaxis for prevention of secondary cases should be limited to 

close contacts of cases in the household setting who are vulnerable to severe 

complications of pertussis, or who, in settings such as early childhood education 

and care or healthcare facilities, may transmit pertussis to vulnerable contacts. 

Further recommendations regarding chemoprophylaxis of close contacts can be 

found in the national guidelines for control of pertussis. 72 






The product information for Quadracel states that this vaccine is indicated for 

use in a 3-dose primary schedule from the age of 2 months to 12 months and 

may also be used as a booster dose for children from 15 months to 6 years of age 

who have previously been vaccinated against diphtheria, tetanus, pertussis and 

poliomyelitis. The ATAGI recommends that, when appropriate, this product may 

also be used for either catch-up of the primary schedule or as a booster dose in 

children aged







References 




4.13 PNEUMOCOCCAL DISEASE 


Streptococcus pneumoniae (pneumococcus) is a Gram-positive coccus. The 

polysaccharide capsule is the most important virulence factor of pneumococci. 1,2 

Over 90 capsular antigenic types (serotypes) have been recognised, each of which 

elicits type-specific immunity in the host. 3,4 The natural reservoir of pneumococci 

is the mucosal surface of the upper respiratory tract of humans. 1,3 In a large 

majority of hosts, pneumococci are carried with no apparent symptoms. Different 

pneumococcal serotypes vary in their propensity to cause nasopharyngeal 

colonisation or disease. Worldwide, only a limited number of serotypes are 

responsible for most cases of invasive pneumococcal disease (IPD) but the 

predominant serotypes vary by age group and geographic area. 5,6 Antibiotic 

resistance in pneumococci is an increasing challenge; in 2006, 11% of Australian 

IPD isolates were non-susceptible to penicillin and 3% were non-susceptible to 

ceftriaxone/cefotaxime. 7 


Person-to-person transmission of S. pneumoniae occurs via contact with 

respiratory droplets of colonised persons. Almost all pneumococcal disease 

probably begins with the establishment of nasopharyngeal colonisation. From 

the nasopharynx, pneumococci may spread locally into adjacent sites to cause 

sinusitis, otitis media or pneumonia. Pneumococci may enter the bloodstream, 

and also localise in the meninges, causing meningitis, or at other sites including 

bones, joints and soft tissues. 1-3,5 For disease surveillance purposes, detection 

of S. pneumoniae in a normally sterile site, such as blood, cerebrospinal fluid 

or pleural fluid, by culture or nucleic acid testing, is classified as IPD. The 

major clinical categories of IPD are meningitis, bacteraemic pneumonia, and 

bacteraemia without focus. In adults, pneumonia with bacteraemia is the most 

common manifestation of IPD. Although more difficult to measure for nonbacteraemic 

cases, it is estimated that pneumococci account for over one-third of 

all community-acquired pneumonia and up to half of hospitalised pneumonia 

in adults. 2,8 In children, the most common manifestation is bacteraemia without 

focus, accounting for approximately 70% of IPD, followed by pneumonia with 

bacteraemia. Meningitis, although least common, is the most severe category of 

IPD and has an estimated case-fatality rate of about 30%. 1,2 Acute otitis media 

(AOM) is the most common non-invasive manifestation of pneumococcal disease 

in children. S. pneumoniae is detected in 28 to 55% of middle ear aspirates from 

children with AOM. 2,5,9 

Immunocompromised persons who are unable to mount an adequate immune 

response to pneumococcal capsular antigens, including those with asplenia, 

have the highest risk of IPD. 1,2,4 Household crowding, exposure to cigarette 

smoke, childcare attendance, excessive alcohol consumption and certain nonimmunocompromising 

chronic medical conditions are also associated with 


4.13 PNEUMOCOCCAL DISEASE

greater risk and/or severity of IPD. 1,2,10,11 Indigenous populations in developed 

countries, including Aboriginal and Torres Strait Islander people in Australia, 

have a disproportionately high burden of IPD. 1,12,13 


The highest incidence of IPD is seen at the extremes of age, in young children 

and the elderly. 5,7 In Australia, vaccination with 7-valent pneumococcal 

conjugate vaccine (7vPCV) was first funded under the NIP from mid-2001, to 

5 years of age for Indigenous children living in Central Australia and children 

with specified predisposing medical conditions, and to 2 years of age for non- 

Indigenous children living in Central Australia and Indigenous children in the 

rest of the country. One dose of the 23-valent pneumococcal polysaccharide 

vaccine (23vPPV) at 18–24 months of age, as a booster following a primary 

7vPCV schedule, was also funded for Indigenous children without predisposing 

medical conditions living in jurisdictions with the highest incidence of IPD (the 

Northern Territory, Queensland, South Australia and Western Australia). From 

January 2005, NIP-funded 7vPCV was extended to all infants nationally, together 

with catch-up vaccination for all children aged

non-Indigenous children (88%). 19,20 Since the implementation of the universal 

7vPCV program, increased rates of IPD caused by certain serotypes not 

contained in 7vPCV (replacement disease) have been observed in Australia and 

several other countries. This is particularly so among non-Indigenous children 

aged

Pneumococcal conjugate vaccines 

• Synflorix – GlaxoSmithKline (10-valent pneumococcal conjugate 

vaccine; 10vPCV). Each 0.5 mL monodose vial or pre-filled syringe 

contains 1 µg of pneumococcal capsular polysaccharide of serotypes 

1, 5, 6B, 7F, 9V, 14, 23F and 3 µg of serotype 4, conjugated to a total of 

9–16 µg of non-typeable H. influenzae protein D, 3 µg of serotype 18C 

conjugated to 5–10 µg of tetanus toxoid carrier protein, and 3 µg of 

serotype 19F conjugated to 3–6 µg of diphtheria toxoid carrier protein, 

adsorbed onto 0.5 mg aluminium as aluminium phosphate. 

• Prevenar 13 – Pfizer Australia Pty Ltd (13-valent pneumococcal 

conjugate vaccine; 13vPCV). Each 0.5 mL monodose pre-filled syringe 

contains 2.2 µg each of pneumococcal capsular polysaccharide of 

serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 µg of 

serotype 6B, conjugated to non-toxic Corynebacterium diphtheriae 

CRM 197 protein, adsorbed onto 0.565 mg aluminium phosphate; 

succinic acid; polysorbate 80. 

7-valent pneumococcal conjugate vaccine (7vPCV) 

A 7vPCV with the mutant non-toxic diphtheria CRM protein as the conjugating 

197 

protein (Prevenar) became available in Australia in 2001. Efficacy data on the 

7vPCV from a pivotal trial in the United States found greater than 95% protective 

efficacy against IPD caused by the serotypes contained in the vaccine. 22 A 

Cochrane review of clinical trials estimated an efficacy of 80% against vaccinetype 

IPD for PCVs (most, but not all, of which used CRM as the conjugating 

197 

protein) in children

10-valent pneumococcal conjugate vaccine (10vPCV) 

10vPCV has been registered for use in Australia since 2009 and is included under 

the NIP. The protein D of non-typeable H. influenzae (NTHi) is one of the main 

conjugating proteins in this vaccine. This vaccine was used for all children aged 

of superior effectiveness against IPD or non-IPD pneumonia, the relative benefit 

of 13vPCV over 23vPPV for adults is uncertain, since the serotype coverage of 

13vPCV is more limited. It is also uncertain whether the level of reduction in 

IPD due to the additional serotypes contained in 13vPCV among adults (herd 

immunity effect) will be similar to that seen following widespread use of 7vPCV 

in children. 

Pneumococcal polysaccharide vaccine 

• Pneumovax 23 – CSL Limited/Merck & Co Inc (23-valent 

pneumococcal polysaccharide vaccine; 23vPPV). Each 0.5 mL 

monodose vial contains 25 µg each of pneumococcal capsular 

polysaccharide of serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 

12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F; 0.25% phenol. 

23vPPV contains polysaccharides derived from the 23 most frequent or most 

virulent capsular types of S. pneumoniae isolated from sterile fluids in the United 

States in the 1970s/early 1980s, with worldwide serotype distribution and 

potential cross-reactive serotypes also taken into consideration. 42 These serotypes 

are responsible for most IPD cases in adults in Australia. 23vPPV induces 

significant immune responses in immunocompetent adults, including the elderly, 

with no substantial differences in immune response between older and younger 

subjects, but poor responses in the immunocompromised. 43 In children 65 years. 54 

There are no studies on the effectiveness of revaccination with 23vPPV for 

disease endpoints, although significant and sustained antibody responses 

after revaccination are seen in adults, including the elderly. 55-59 Evidence of 


lesser antibody responses to 2nd or subsequent doses of 23vPPV in adults is 

variable, 55-58,60 and, even if present, its correlation with clinical effectiveness is 

unknown. 



+2°C to +8°C. Do not freeze. 

10vPCV should be protected from light. 


The dose of pneumococcal conjugate vaccines (10vPCV, 13vPCV) is 0.5 mL, to 

be given by IM injection, in the opposite limb to other injectable vaccines, if 

possible. 

The dose of pneumococcal polysaccharide vaccine (23vPPV) is 0.5 mL, to be 

given by either IM or SC injection, in the opposite limb to other injectable 

vaccines, if possible. The IM route is preferred, as a 3-fold greater rate of injection 

site reactions is found following administration of 23vPPV by the SC route. 62 

However, a vaccine dose administered subcutaneously does not need to be 

repeated. 

10vPCV (Synflorix) is registered for use in infants and children aged 

6 weeks up to 5 years. 

13vPCV (Prevenar 13) is registered for use in infants and children aged 

6 weeks up to 5 years and adults aged ≥50 years. 

23vPPV (Pneumovax 23) is registered for use in children aged ≥2 years 

and in adults. 


10vPCV may be concurrently administered with other vaccines routinely 

used in the infant schedule. 

13vPCV may be concurrently administered with other vaccines in the infant 

schedule, including inactivated trivalent influenza vaccine. However, parents/ 

carers of infants or children who are recommended to receive both influenza 

vaccine and 13vPCV should be advised of the increased risk of fever following 

concomitant administration of these vaccines (see 4.13.10 Precautions below). 

Simultaneous administration of Zostavax with pneumococcal polysaccharide 

vaccine is not routinely recommended; if possible, the two vaccines should 

be given at least 4 weeks apart. However, inadvertent administration of 

Zostavax and pneumococcal polysaccharide vaccine at the same time or at an 

interval of less than 4 weeks does not require revaccination. One clinical trial 

showed reduced immunogenicity of Zostavax in subjects who received both 

vaccines concomitantly, compared with those who received Zostavax alone; the 

immunogenicity of 23vPPV was not affected by concurrent administration. 63 



However, an observational study from the United States suggests this may not 

impact on Zostavax effectiveness. 64-66 (See also 4.24 Zoster.) 

Interchangeability of 10vPCV and 13vPCV 

There are no available specific data on the interchangeability of 10vPCV and 

13vPCV. Although completion of a primary course of pneumococcal conjugate 

vaccine with the same formulation is generally preferred, if vaccination with 

10vPCV is commenced (e.g. in children born overseas), completion of the course 

with 13vPCV is acceptable. 


Children aged


aged

• Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV 

(Pneumovax 23) in children with a medical condition(s) associated with an increased 

risk of IPD, presenting at age

Category B: Conditions associated with an increased risk of IPD 

• chronic cardiac disease 

» particularly cyanotic heart disease or cardiac failure in children 

» excluding hypertension only (in adults) 

• chronic lung disease, including: 

» chronic lung disease in preterm infants 

» cystic fibrosis 

» severe asthma in adults (requiring frequent hospital visits and use of 

multiple medications) 

• diabetes mellitus 

• Down syndrome 

• alcoholism 

• chronic liver disease 

• preterm birth at 5 years (but not for 

those aged

Indigenous children residing in the Australian Capital Territory, New South Wales, 

Tasmania and Victoria, who do not have any medical condition(s) associated with an 

increased risk of IPD, aged

Children aged >5 years to 15 years) who 

have an increased risk of IPD, especially in the Northern Territory, where a dose 

of 23vPPV is provided to all Indigenous adolescents at approximately 15 years of 

age, based on the very high prevalence of conditions associated with an increased 

risk of IPD and incidence of IPD in this sub-population (see ‘Adults aged 

≥18 years’ below and 3.1 Vaccination for Aboriginal and Torres Strait Islander people). 

For children with a medical condition(s) associated with an increased risk of 

IPD, further pneumococcal vaccine doses are recommended, as discussed below, 

depending on the child’s level of risk. 

Those with the highest increased risk of IPD (List 4.13.1, Category A) 

Children aged >5 to 5 to

adult 23vPPV dose. Based on current evidence, 13vPCV is not specifically 

recommended for children in this age and risk group, regardless of previous 

vaccination history. 

For children in this age group with a newly identified medical condition(s) 

associated with an increased risk of IPD (List 4.13.1, Category B), a single dose 

of 23vPPV is recommended at the time of diagnosis. In the rare situation where 

a previous dose of 23vPPV has been given (e.g. in Indigenous children in some 

jurisdictions), this dose should be given at least 5 years after the previous 23vPPV 

dose. The next 23vPPV dose should be given approximately 5–10 years after the 

1st 23vPPV dose and counted as their 1st adult 23vPPV dose (see ‘Adults with a 

condition(s) associated with an increased risk of IPD’ below). 


The recommendations for use of 23vPPV in adults who do not have a 

condition(s) associated with an increased risk of IPD are summarised in Table 

4.13.3. Recommendations for the use of 13vPCV and/or 23vPPV in adults with a 

condition(s) associated with an increased risk of IPD (List 4.13.1, Category A or 

B) are described in the text below. 

The number of doses recommended depends on age, Indigenous status and the 

presence of a condition(s) associated with an increased risk of IPD. Up to 3 doses 

(i.e. 2 revaccinations) of 23vPPV in adulthood are recommended, depending on 

these factors. This is based on limited data on adverse events and effectiveness, 

as well as uncertainty regarding the clinical significance of blunting of antibody 

response (immune hyporesponsiveness) following revaccination with 23vPPV, 

especially with multiple revaccinations. 

For adults, prior childhood doses of 23vPPV that may have been given at either 

18–24 months and/or 4–5 years of age should not be counted; that is, they are not 

relevant to the recommendations given in Table 4.13.3. In the Northern Territory, 

a dose of 23vPPV is provided to all Indigenous adolescents at approximately 

15 years of age, based on the very high prevalence of conditions associated with 

an increased risk of IPD and incidence of IPD in this population; this dose should 

be considered as a dose received in adulthood for the purpose of limiting the 

total lifetime number of 23vPPV doses to 3. 

Although 13vPCV is registered for use in adults aged ≥50 years, there is currently 

insufficient evidence to recommend its use in preference to 23vPPV at the 

individual or population level for persons aged ≥18 years who do not have a 

condition(s) associated with an increased risk of IPD (see 4.13.4 Vaccines above). 

Updated recommendations on the use of 13vPCV in adults without an increased 

risk of IPD will be made when more data are available (see Immunise Australia 

website www.immunise.health.gov.au). 


Non-Indigenous adults 

A single dose of 23vPPV is recommended for adults at 65 years of age. For those 

aged >65 years who did not receive a dose at 65 years of age, a single catch-up 

dose of 23vPPV should be offered as soon as possible. Routine revaccination with 

23vPPV for non-Indigenous adults without a condition(s) associated with an 

increased risk of IPD is not recommended (see Table 4.13.3). 

Aboriginal and Torres Strait Islander (Indigenous) adults 

A 1st dose of 23vPPV is recommended for all Indigenous adults reaching the age 

of 50 years (Table 4.13.3). This is based on the increased risk of IPD in Indigenous 

adults compared with non-Indigenous adults, and the high prevalence of 

conditions associated with an increased risk of IPD (including tobacco smoking) 

in Indigenous adults after 50 years of age, compared with younger ages. A 2nd 

dose of 23vPPV is recommended 5 years after the 1st dose. For those aged 

≥50 years who have never received a dose of 23vPPV, a 1st dose should be 

offered as soon as possible, with a 2nd dose recommended 5 years after the 

1st dose. 

Indigenous adults aged

Table 4.13.3: Recommendations for pneumococcal vaccination using 23vPPV 

for adults who do not have a condition(s) associated with an 

increased risk of invasive pneumococcal disease (IPD)* 

Non-Indigenous adults 

Current age (years) 1st dose of 23vPPV 2nd dose of 

23vPPV 

(1st revaccination) 


3rd dose of 23vPPV 

(2nd revaccination) 

18 to

Adults who have a condition listed in Category B in List 4.13.1 are not 

recommended to receive 13vPCV. 13vPCV is registered for use in children up 

to the age of 5 years only and in adults aged ≥50 years, and data in adults and 

in immunocompromised persons is limited. However, based on extrapolation 

from data on the 7vPCV, 76 providing a dose of 13vPCV to adults at the highest 

increased risk of IPD is likely to be beneficial. 

Use of 23vPPV 

All adults with a condition(s) associated with an increased risk of IPD (List 4.13.1, 

Categories A and B) are recommended to receive additional doses of 23vPPV 

(compared with those who do not have an increased risk). 

In adults with a pre-existing condition (List 4.13.1, Categories A and B) the 1st 

adult dose of 23vPPV is recommended at approximately 18 years of age (see also 

‘Children aged >5 years to


23vPPV is not routinely recommended for pregnant or breastfeeding women. 

Although 23vPPV has been administered in pregnancy in the context of 

clinical trials77 with no evidence of adverse effects, data are limited; deferral of 

vaccination with 23vPPV until after delivery is recommended unless there is 

an increased risk of IPD. Women of child-bearing age who have a condition(s) 

associated with an increased risk of IPD should be vaccinated before a planned 

pregnancy, or as soon as practicable after delivery (see 4.13.7 Recommendations 

above). 23vPPV may be given to breastfeeding women. 

Data on use the use of 10vPCV and 13vPCV during pregnancy or lactation are 

not available. For adults with a condition(s) associated with an increased risk of 

IPD for whom a dose of 13vPCV is recommended, the dose should be deferred 

until after delivery and cessation of breastfeeding. 




The only absolute contraindications to pneumococcal vaccines are: 

• anaphylaxis following a previous dose of any pneumococcal vaccine 



13-valent pneumococcal conjugate vaccine and inactivated influenza vaccines 

One study in the United States has suggested that there is a slightly higher 

risk of febrile seizure associated with concurrent administration of 13vPCV 

and inactivated trivalent influenza vaccine than after receipt of either of the 

vaccines alone on separate days. 67 The increased likelihood of febrile seizures 

occurred within 1 day of vaccination in children aged 6–59 months who 

received 13vPCV concurrently with a 1st dose of inactivated trivalent influenza 

vaccine. The risk was estimated to be about 18 excess cases per 100 000 doses 

for those aged 6–59 months, with a peak of 45 per 100 000 doses for those 

aged 16 months. Given this relatively low increase in risk, providing 13vPCV 

and inactivated trivalent influenza vaccine concurrently to children aged 

12–23 months is acceptable; however, immunisation service providers should 

advise parents regarding this, and provide the option of administering these 

two vaccines on separate days (with an interval of not less than 3 days). (See 

also 4.7 Influenza.) In the event that fever occurs following either vaccine, an 

interval may minimise the risk of increased adverse reactions. 



10-valent pneumococcal conjugate vaccine 

The safety profile of 10vPCV is similar to that of 7vPCV, 68 with no clinically 

relevant difference when co-administered with routine childhood vaccines. 69 

In clinical trials, erythema, pain, or swelling of any degree at the injection site 

each occurred in approximately 30 to 50% of 10vPCV recipients. Erythema 

of >30 mm occurred in up to about 5% of 10vPCV recipients in the primary 

course. The frequency of local adverse events was higher after the booster 

dose. Irritability and drowsiness were reported in about 50% of 10vPCV 

recipients when co-administered with a DTPa-combination vaccine, but severe 

reactions occurred in fewer than 5%. When co-administered with DTPa-based 

combination vaccines, fever with temperature ≥38°C was reported in about 33% 

of 10vPCV recipients after primary or booster doses. Approximately 2 to 6% of 

10vPCV recipients reported rectal temperature >39°C after primary vaccination 

and 1.5 to 3% after booster vaccination. 68 

13-valent pneumococcal conjugate vaccine 

Pooled safety analysis from 13 clinical trials showed that the safety profile of 

13vPCV in young children is similar to that of 7vPCV. 70,78 Pain/tenderness and 

erythema at the injection site occurred in about 50% of all 13vPCV recipients, and 

induration or swelling in about 33%. Pain interfering with movement occurred 

in about 8%. Moderate erythema and induration occurred more commonly after 

the toddler dose than after an infant dose, in about 13% of recipients. About 

37% of 13vPCV childhood recipients reported fever, with about 5% reporting 

fever >39°C. 78 Fever occurred more frequently after the toddler dose than after 

the primary doses. 79 Other common systemic reactions included irritability, 

drowsiness/increased sleep and decreased appetite, reported in 70%, 60% and 

39% of 13vPCV recipients, respectively. 78 Frequencies of each of these adverse 

events were comparable to those in 7vPCV recipients. 78 

Post-marketing surveillance in the United States has suggested the possibility 

of a higher risk of febrile seizure within a day of vaccination among those who 

received concurrent administration of 13vPCV and inactivated trivalent influenza 

vaccine in 2010–2011, compared with those who received either vaccine alone, 

especially in children aged 12–23 months (see 4.13.10 Precautions above). 67 

There is only limited information available on the safety of 13vPCV use in 

adults, from a study in which adults aged ≥65 years received 13vPCV with or 

without concurrent vaccination with the trivalent seasonal influenza vaccine. 80 

Pain, redness and/or swelling at the 13vPCV injection site were very common, 

occurring in 47% in both groups. The common systemic reactions that were 

reported significantly more often among 13vPCV than placebo recipients, both 

concurrently receiving the trivalent influenza vaccine, were chills, rash and new 

muscle pain. Overall, there were no significant differences in adverse event 



frequencies between those with or without prior 23vPPV doses. Recipients of 

concurrent administration of inactivated trivalent seasonal influenza vaccine 

with 13vPCV reported a higher frequency of systemic but not local reactions. 80 

23-valent pneumococcal polysaccharide vaccine 

The proportion of vaccine recipients reporting local and systemic reactions after a 

primary or a repeat dose of pneumococcal polysaccharide vaccines varies among 

different study populations, and possibly with age. 55,57,81 About 50% or more of 

23vPPV recipients will experience some soreness after the 1st dose, and swelling 

and redness are also very common, occurring in approximately 20% of recipients. 

Moderate or severe local adverse events that limit arm movement are also quite 

common, occurring in up to 5% of 1st dose recipients. Systemic reactions like 

myalgia, fatigue and chills are also very common. Fever ≥37.5°C occurs in up to 

10% of 23vPPV recipients, but high fever is uncommon. 55,57,81 

Larger and more recent studies indicate that both local and systemic adverse 

events occur more commonly after a repeat dose of 23vPPV than after the 

1st dose in adults, particularly more severe local adverse events, which may 

occur in up to approximately 20% of revaccinated subjects. 55,57,81 These findings 

effectively supersede the inconsistent findings from some smaller studies, which 

were limited by subject numbers and methodology. 82-86 Nevertheless, the local 

adverse events were mostly non-serious and self-limiting. In these studies, the 

repeat doses were given at least 5 years after the previous dose. Another study, 

which used hospitalisations coded as cellulitis or abscess of the upper limb 

within 3 days of pneumococcal vaccination as a proxy measure for very severe 

local adverse events, showed that these adverse events were significantly more 

likely when a repeat dose was given within 5 years of the 1st dose. 87 As severe 

local reactions are also associated with higher antibody levels, 57,62,81,88 this is the 

likely driver of the relationship with shorter intervals between the repeat and 

the primary dose and suggests that such local reactions are associated with more 

robust immunity. 


The product information for Prevenar 13 recommends 4 doses of 13vPCV for 

vaccination commencing at 6 weeks of age, with further doses at 4, 6 and 

12–15 months of age; 3 doses for vaccination commencing between 7 and 

11 months of age; and 2 doses for vaccination commencing between 12 and 

23 months of age. The ATAGI recommends instead that 1 dose less than that 

stated in the product information be given to healthy children who are not at 

increased risk of IPD. The ATAGI recommends that the 1st dose be given at 

2 months of age, and that this dose can be given as early as 6 weeks of age. 

The next scheduled doses should be given at 4 months and 6 months of age. 

13vPCV is registered for use in children up to 5 years of age and adults aged 

≥50 years. The ATAGI recommends a dose of 13vPCV for children aged 


5 years with a condition(s) associated with the highest risk of IPD (see List 

4.13.1, Category A) who have not completed a primary course of 13vPCV, or 

who have not received a supplementary dose of 13vPCV before (see 4.13.7 

Recommendations above), or for adults of any age who have a condition(s) 

associated with the highest risk of IPD. This is based on the likely benefit 

outweighing uncertainties and risks, and on immunogenicity and safety data in 

younger children. 

The product information for Pneumovax 23 states that Pneumovax 23 and 

Zostavax should not be given concurrently. The ATAGI instead recommends that 

while concurrent administration of Zostavax with pneumococcal polysaccharide 

vaccine is not routinely recommended, and if possible the two vaccines should 

be given at least 4 weeks apart, inadvertent administration of Zostavax and 

pneumococcal polysaccharide vaccine at the same time or at an interval of less 

than 4 weeks does not require revaccination. 

References 





4.14 POLIOMYELITIS 


Polioviruses are classified as enteroviruses in the family Picornaviridae. 1 They 

have an RNA genome, and can inhabit the gastrointestinal tract transiently. 

There are three poliovirus serotypes, referred to as either type 1, type 2 or type 3. 

The virus enters through the mouth, multiplies in the pharynx and gut and is 

excreted in the stools for several weeks. The virus invades local lymphoid tissue, 

enters the bloodstream and may then infect and replicate in cells of the central 

nervous system. 2 


Poliomyelitis is an acute illness following gastrointestinal infection by one of the 

three types of poliovirus. Transmission is through faecal–oral and, occasionally, 

oral–oral spread. 3 The infection may be clinically inapparent. If symptoms 

occur, they may include headache, gastrointestinal disturbance, malaise and 

stiffness of the neck and back, with or without paralysis. Paralysis is classically 

asymmetrical. Paralytic polio is a complication of poliovirus aseptic meningitis, 

and may be spinal (79%), bulbar (2%) or bulbospinal (19%). The case-fatality 

rate in paralytic polio is 2 to 5% in children and 15 to 30% in adults. The casefatality 

rate in bulbar polio is up to 75%. The infection rate in households 

with susceptible young children can reach 100%. The ratio of inapparent or 

asymptomatic infection to paralytic infection may be as high as 1000:1 in 

children and 75:1 in adults, depending on the poliovirus type and social and 

environmental conditions. 2 

The incubation period ranges from 3 to 21 days. Infected persons are most 

infectious from 7 to 10 days before to 7 to 10 days after the onset of symptoms. 

The oral vaccine virus may be shed in the faeces for 6 weeks or more, 2 and for up 

to several years in people who are immunocompromised. Oral vaccine strains 

shed for many years may mutate into potentially neurovirulent strains. 4-9 


The incidence of poliomyelitis has been dramatically reduced worldwide with 

the World Health Organization (WHO) aiming to achieve cessation of all wild 

poliovirus transmission worldwide by 2013 through an intensified Global Polio 

Eradication Initiative. There have been imported poliomyelitis case reports in 

parts of Southeast Asia, eastern Europe and Africa. 10-12 Further information is 

available from the WHO Polio Eradication website (www.polioeradication.org). 

In 1994, the continents of North and South America were certified to be free of 

polio, 13 followed by the Western Pacific region (including Australia) in 200014 and the European region in 2002. 15 In countries where the disease incidence is 

low but transmission is still occurring, poliomyelitis cases are seen sporadically 

or as outbreaks among non-vaccinated persons. In 2012, polio had been 


virtually eradicated in India, but there were still cases in Afghanistan, Nigeria 

and Pakistan. 16 

In Australia, the peak incidence of poliomyelitis was 39.1/100 000 in 1938. There 

has been a dramatic fall in incidence since 1952, but epidemics occurred in 1956 

and 1961–62. The most recent laboratory-confirmed case of wild poliomyelitis 

in Australia occurred in 2007 in an overseas-born student who acquired the 

disease during a visit to Pakistan. 17 The last case of wild poliomyelitis prior to 

this was in 1977, due to an importation from Turkey, but two vaccine-associated 

cases were notified in 1986 and 1995. 18,19 Because of the rapid progress in global 

polio eradication and the diminished risk of wild virus-associated disease, 

inactivated poliomyelitis vaccine (IPV) is now used for all doses of polio vaccine 

in Australia. 3,20 The advantage of using IPV is that it cannot cause vaccineassociated 

paralytic poliomyelitis (VAPP). 21 Emergence of highly evolved 

vaccine-derived polioviruses (VDPV) in persons with primary immunodeficiency 

(iVDPV) with long-term excretion, and polio outbreaks due to circulating VDPV 

(cVDPV), particularly in areas with low vaccine coverage, are associated with 

oral poliomyelitis vaccine (OPV) administration. 22,23 


Inactivated poliomyelitis vaccine 

• IPOL – Sanofi Pasteur Pty Ltd (IPV; inactivated poliovirus). Each 

0.5 mL pre-filled syringe contains 40 D-antigen units inactivated 


32 D-antigen units type 3 (Saukett); 2–3 µL phenoxyethanol; 2–20 µg 

formaldehyde; polysorbate 80; traces of neomycin, streptomycin, 

polymyxin B and bovine serum albumin. 

Combination vaccines that contain IPV 


polysaccharide (PRP) conjugated to 20–40 µg tetanus toxoid. May 

contain yeast proteins. 

• Infanrix IPV – GlaxoSmithKline (DTPa-IPV; diphtheria-tetanusacellular 


syringe contains ≥30 IU diphtheria toxoid, ≥40 IU tetanus toxoid, 

25 µg PT, 25 µg FHA, 8 µg PRN, 40 D-antigen units inactivated 



hydroxide; traces of formaldehyde, polysorbate 80, polymyxin and 

neomycin. 



b). Each 0.5 mL monodose vial contains ≥30 IU diphtheria toxoid, 

≥40 IU tetanus toxoid, 20 µg PT, 20 µg FHA, 3 µg PRN, 5 µg pertussis 

fimbriae (FIM) 2+3, 40 D-antigen units inactivated poliovirus type 

1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen 

units type 3 (Saukett), 10 µg Hib capsular polysaccharide conjugated 

to 20 µg tetanus protein; 1.5 mg aluminium phosphate; ≤50 ng 

bovine serum albumin; phenoxyethanol as preservative; traces of 











neomycin. 

Reduced antigen formulations for adults, adolescents and children aged ≥10 years 



















IPV (IPOL) and IPV-containing combination vaccines contain polioviruses 

of types 1, 2 and 3 inactivated by formaldehyde. A course of 3 doses with an 

interval of 2 months between each dose produces long-lasting immunity (both 

mucosal and humoral) to all three poliovirus types. IPV produces considerably 

lower levels of intestinal immunity than OPV. 









The dose of IPV (IPOL) is 0.5 mL, to be given by SC injection. If IPV (IPOL) is 

inadvertently given intramuscularly, there is no need to repeat the dose. 

The dose of the IPV-containing combination vaccines is 0.5 mL, to be given by 

IM injection. 

The primary course consists of 3 doses of vaccine. An interval of 2 months 

between doses is recommended, but the minimum interval can be as short as 

1 month for catch-up in children or adults. 

Interchangeability of oral and inactivated poliomyelitis vaccine 

OPV is no longer in use in Australia. OPV and IPV are interchangeable. 

Children commenced on OPV should complete their polio vaccination schedule 

using IPV (IPOL) or IPV-containing vaccines. 25 


4.14 POLIOMYELITIS


Primary vaccination of infants and children 

IPV (IPOL) or IPV-containing vaccines are recommended for infants at 2, 4 and 

6 months of age. The 1st dose of an IPV-containing vaccine can be given as 

early as 6 weeks of age. If the 1st dose is given at 6 weeks of age, the next 

scheduled doses should still be given at 4 months and 6 months of age. An 

open, randomised, multi-centre trial comparing the hexavalent and pentavalent 

IPV-containing vaccines found that infants receiving either vaccine at 2, 4 and 

6 months of age had seroprotective levels of antibody to poliovirus types 1, 2 

and 3. 26 Extra doses of IPV (IPOL) or IPV-containing vaccines are not needed for 

babies born prematurely. 

Where only IPV vaccination is required, IPOL can be used for catch-up in 

children. If other antigens including poliomyelitis are required, Infanrix IPV 

or Infanrix hexa can be used for catch-up in children aged


IPV (IPOL) or IPV-containing vaccines are not routinely recommended for 

pregnant or breastfeeding women, but can be given where vaccination is 

considered necessary (see 4.14.7 Recommendations above). 




The only absolute contraindications to IPV (IPOL) or IPV-containing vaccines are: 

• anaphylaxis following a previous dose of any IPV-containing vaccine 



IPV (IPOL) or IPV-containing vaccines cause erythema (in 33% of vaccine 

recipients), pain (in 13%), and induration (in 1%) at the injection site. Other 

symptoms reported in young babies are fever, crying and decreased appetite (in 

5 to 10%). 

Repeat doses of IPV or IPV-containing vaccines have not been associated with 

increased adverse events and, where extra doses are required, are safe. 

4.14.11 Public health management of poliomyelitis 

Poliomyelitis is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of poliomyelitis, 

including management of cases of poliomyelitis and their contacts, should 









The product information for Quadracel states that this vaccine is indicated for 

use in a 3-dose primary schedule from the age of 2 months to 12 months and 

may also be used as a booster dose for children from 15 months to 6 years of age 

who have previously been vaccinated against diphtheria, tetanus, pertussis and 

poliomyelitis. The ATAGI recommends that, when appropriate, this product may 

also be used for either catch-up of the primary schedule or as a booster dose in 

children aged

4.15 Q FEVER 


Q fever is caused by Coxiella burnetii, an obligate intracellular bacterium. 1 The 

organism is inactivated at pasteurisation temperatures. It survives well in air, 

soil, water and dust, and may also be disseminated on fomites such as wool, 

hides, clothing, straw and packing materials. 2,3 C. burnetii has been weaponised 

and is considered a Category B biothreat agent. 4 


Q fever can be acute or chronic, and there is increasing recognition of long-term 

sequelae. Infection is asymptomatic in at least half of cases. 5,6 

Acute Q fever usually has an incubation period of 2 to 3½ weeks, depending on 

the inoculum size and other variables7 (range from 4 days up to 6 weeks). Clinical 

symptoms vary by country, but, in Australia, the most common presentation is 

rapid onset of high fever, rigors, profuse sweats, extreme fatigue, muscle and 

joint pain, severe headache and photophobia. 5,6 As the attack progresses, there 

is usually evidence of hepatitis, occasionally with frank jaundice; a proportion 

of patients may have pneumonia, which is usually mild but can require 

mechanical ventilation. If untreated, the acute illness lasts 1 to 3 weeks and may 

be accompanied by substantial weight loss in more severe cases. 5,6 Infection often 

results in time off work, lasting a few days to several weeks. 8 

C. burnetii may cause chronic manifestations, the most commonly 

reported being subacute endocarditis. Less common presentations include 

granulomatous lesions in bone, joints, liver, lung, testis and soft tissues. 

Infection in early pregnancy, or even before conception, may recrudesce at term 

and cause fetal damage. 9-11 

Studies have also identified a late sequela to infection, post Q fever fatigue 

syndrome (QFS), which occurs in about 10 to 15% of patients who have 

previously had acute Q fever. 12-15 Research suggests that non-infective antigenic 

complexes of C. burnetii persist for many years after acute Q fever, and the 

maintenance of immune responses to these antigens might be the biological basis 

by which QFS occurs. 13,16-18 


C. burnetii infects both wild and domestic animals and their ticks, with cattle, 

sheep and goats being the main sources of human infection. 19-21 Companion 

animals such as cats and dogs may also be infected, as well as native Australian 

animals such as kangaroos, and introduced animals such as feral cats and 

camels. 19,21-23 The animals shed C. burnetii into the environment through their 

placental tissue or birth fluids, which contain exceptionally high numbers of 

Coxiella organisms, and also via their milk, urine and faeces. C. burnetii is highly 

infectious24 and can survive in the environment. The organism is transmitted to 


4.15 Q FEVER

humans via the inhalation of infected aerosols or dust. Those most at risk include 

workers from the meat and livestock industries and shearers, with non-immune 

new employees or visitors being at highest risk of infection. Nevertheless, 

Q fever is not confined to occupationally exposed groups; there are numerous 

reports of sporadic cases or outbreaks in the general population in proximity to 

infected animals in stockyards, feedlots, processing plants or farms. Although 

most notifications occur among men from rural areas or with occupational 

exposure, a recent serosurvey from Queensland indicated a high rate of exposure 

among urban residents, including women and children. 25 

Use of Q fever vaccine in Australia can be considered in 4 periods: from 1991 

to 1993, when vaccine was used in a limited number of abattoirs; from 1994 

to 2000, when vaccination steadily increased to cover large abattoirs in most 

states; 26 from 2001 to 2006, during the period of the Australian Government 

sponsored National Q fever Management Program (NQFMP); 27 and the period 

since 2007 after the NQFMP finished, where the vaccination remains available 

on the private market. The NQFMP funded screening and vaccination of abattoir 

workers and shearers and then extended vaccination to farmers, their families 

and employees in the livestock-rearing industry. Following introduction of 

the program, the number of Q fever cases reported to the National Notifiable 

Diseases Surveillance System declined by over 50% (see Figure 4.15.1), 27 with 

the greatest reductions among young men aged 15–39 years, consistent with 

high documented vaccine uptake among abattoir workers. 26-28 As a result, other 

occupational groups as well as non-occupational animal exposures appear to be 

accounting for an increasing proportion of notifications. 8,29 

Figure 4.15.1: Q fever notifications for Australia, New South Wales and 

Queensland, 1991 to 2009 30 


14 

12 

10 

8 

6 

4 

2 

0 

1991 

1992 

1993 

1994 

1995 

1996 

1997 

1998 

1999 

2000 

2001 

Year 

2002 

2003 


National Q Fever Management 

Program Phase 1 

Phase 2 implementation 

July 2002 to June 2005 

2004 

2005 

2006 

2007 

2008 

2009 

Qld 

NSW 

Aust

4.15.4 Vaccine 

• Q-Vax – CSL Limited (Q fever vaccine). Each 0.5 mL pre-filled 

syringe contains 25 µg purified killed suspension of Coxiella burnetii; 

thiomersal 0.01% w/v. Traces of formalin. May contain egg proteins. 

• Q-Vax Skin Test – CSL Limited (Q fever skin test). Each 0.5 mL liquid 

vial when diluted to 15 mL with sodium chloride contains 16.7 ng 

of purified killed suspension of C. burnetii in each diluted 0.1 mL 

dose; thiomersal 0.01% w/v before dilution. Traces of formalin. May 

contain egg proteins. 

The Q fever vaccine and skin test consist of a purified killed suspension of 

C. burnetii. It is prepared from the Phase I Henzerling strain of C. burnetii, grown 

in the yolk sacs of embryonated eggs. The organisms are extracted, inactivated 

with formalin, and freed from excess egg proteins by fractionation and 

ultracentrifugation. Thiomersal 0.01% w/v is added as a preservative. 

Phase I whole-cell vaccines have been shown to be highly antigenic and 

protective against challenge, both in laboratory animals and in volunteer trials. 31 

Serological response to the vaccine is chiefly IgM antibody to C. burnetii Phase I 

antigen. In subjects weakly seropositive before vaccination, the response is 

mainly IgG antibody to Phase I and Phase II antigens. 32 Lack of seroconversion 

is not a reliable marker of lack of vaccination. 31 Although the seroconversion 

rate may be low, long-term cell-mediated immunity develops33 and estimates of 

vaccine efficacy have ranged from 83 to 100%, based on the results of open and 

placebo-controlled trials, and post-marketing studies. 34-38 It is important that 

vaccination status is reported for all notified cases and apparent vaccine failures 

are investigated. 

It should be noted that vaccination during the incubation period of a natural 

attack of Q fever does not prevent the development of the disease. 31 

The Q fever vaccine and skin test are available for purchase in Australia through 

the private market. The Australian Government may fund the vaccine and skin 

test in emergency situations where there is a Q fever outbreak. 


Transport the vaccine according to National vaccine storage guidelines: Strive for 5. 39 

Store at +2°C to +8°C. Do not freeze or store in direct contact with ice packs. If 

vaccine has been exposed to temperatures less than 0°C, do not use it. Protect 

from light. 

Diluted Q-Vax Skin Test should be freshly prepared, stored at +2°C to +8°C and 

used within 6 hours. 


4.15 Q FEVER


The dose of Q fever vaccine is 0.5 mL, to be given by SC injection, after 

ascertaining that serological and skin testing have been performed and that both 

tests are negative (see ‘Pre-vaccination testing’ below). 

Q fever vaccination and skin testing training is undertaken via an educational 

video available online. Please contact the manufacturer for access details. 


Children aged

individuals, which can be accessed by registered users. If there is any doubt 

about serological or skin test results, testing should be repeated 2 to 3 weeks 

later (see below for interpretation). 

• Serological and skin test results should be taken into account, according to 

Table 4.15.1, before vaccination. Antibody studies were originally done by 

complement fixation (CF) tests at serum dilutions of 1 in 2.5, 5 and 10 against 

the Phase II antigen of C. burnetii. Although this is generally satisfactory, 

many testing laboratories now use enzyme immunoassay (EIA) or 

immunofluorescent antibody (IFA) to detect IgG antibody to C. burnetii as an 

indicator of past exposure. Subjects who are CF antibody positive at 1 in 2.5, 

IFA positive at 1 in 10 or more, or with a definite positive absorbance value in 

the EIA, should not be vaccinated. 

• Skin testing and interpretation should only be carried out by experienced 

personnel. Details of immunisation service providers trained in the 

administration of Q fever skin testing can be obtained online from the 

Australian Q Fever Register (www.qfever.org). Skin testing is performed 

by diluting 0.5 mL of the Q-Vax Skin Test in 14.5 mL of sodium chloride 

(injection grade). Diluted Q-Vax Skin Test should be freshly prepared, stored 

at +2°C to +8°C and used within 6 hours. A 0.1 mL dose of the diluted Q-Vax 

Skin Test is injected intradermally into the volar surface of the forearm. 

Commercial isopropyl alcohol skin wipes should not be used. If the skin is 

not visibly clean, then methylated spirits may be used. Skin reactions are 

common 3 to 4 days after skin testing; however, these reactions generally 

resolve by day 7 when the skin test is read. A positive reaction is indicated 

by any induration at the site of injection after 7 days. Individuals giving such 

a reaction must not be vaccinated, because they may develop severe local 

reactions. 

• The result of testing is considered ‘indeterminate’ when skin test induration 

is just palpable and the antibody test is either equivocal or negative, or when 

there is no skin induration and an equivocal antibody test (see Table 4.15.1). 

An indeterminate result, which occurs in only a small proportion of subjects, 

may be the consequence of past infection with Q fever. It may also merely 

indicate the presence in the subject of antibodies to antigens shared between 

C. burnetii and other bacteria. Australian Q fever vaccine providers have 

dealt with this finding in one of two ways: 

» Repeat the skin test and interpret as per the guidelines for initial testing. 

Collect serum 2 to 3 weeks later to look for a rise in titre of C. burnetii 

antibodies in the IFA test, using Phase I and Phase II antigens and 

immunoglobulin class analysis. A significant increase (defined as a 

4-fold rise in titre of paired sera) indicates previous Q fever infection and 

vaccination is then contraindicated. 


4.15 Q FEVER

» Vaccinate the subject using SC injection of a 5 µg (0.1 mL) dose instead of 

a 25 µg (0.5 mL) dose of the vaccine. If there are no adverse events (e.g. 

severe local induration or severe systemic effects, perhaps accompanied 

by fever) 48 hours after the injection, a further 0.4 mL (20 µg) dose of 

the vaccine is given within the next 2 to 3 weeks, that is, before the 

development of cell-mediated immunity to the 1st dose. 

Table 4.15.1: Interpretation and action for serological and skin test results (with 

modifications from A guide to Q fever and Q fever vaccination 

(CSL Biotherapies, 2009) 6 ) 

Serology Skin test Interpretation/Action 

Positive antibody test* Any skin test result Sensitised: do not vaccinate 

Equivocal antibody test † 

Negative antibody test # 

Positive ‡ 

Borderline § or Negative 

Positive 

Borderline 

Negative 


Sensitised: do not vaccinate 

Indeterminate (see above) 

Sensitised: do not vaccinate 

Indeterminate (see above) 

Non-immune: vaccinate 

* Positive antibody test: CF antibody or IFA positive (according to criteria used by diagnosing 

laboratory [see above]; or definite positive EIA absorbance value (according to manufacturer’s 

instructions) 

† Equivocal antibody test: CF antibody or IFA equivocal (according to criteria used by diagnosing 

laboratory); or equivocal EIA absorbance value (according to manufacturer’s instructions) 

‡ Positive skin test: induration present 

§ Borderline skin test: induration just palpable 

Negative skin test: no induration 

# Negative antibody test: CF antibody or IFA negative (according to criteria used by diagnosing 

laboratory); or definite negative EIA absorbance value (according to manufacturer’s instructions) 

Booster doses 

Immunity produced by the vaccine appears to be long-lasting (in excess of 

5 years). Until further information becomes available, revaccination or booster 

doses of the vaccine are not recommended because of the risk of accentuated 

local adverse events. 


Q fever vaccine is not routinely recommended for pregnant or breastfeeding 

women. 

Q fever vaccine contains inactivated products; inactivated bacterial vaccines are 

not considered to be harmful in pregnancy. However, safety of the vaccine in 

pregnancy has not been established. No information is available on the use of 

Q fever vaccine during breastfeeding.




Q fever vaccine is contraindicated in the following groups: 

• persons with a history of laboratory-confirmed Q fever, or with medical 

documentation that supports a previous diagnosis of Q fever 

• persons shown to be immune by either serological testing or sensitivity to the 

organism by skin testing 

• persons who have been previously vaccinated against Q fever 

• persons with known hypersensitivity to egg proteins or any component of 

the vaccine (Q-Vax may contain traces of egg protein and formalin). 40 

There is no information available on the accuracy of skin testing or the efficacy 

and safety of Q fever vaccine use in persons who are immunocompromised. In 

general, skin testing and Q fever vaccine should be avoided in such persons. 

There are no data on the safety or efficacy of Q fever vaccine in children. Q fever 

vaccine is not recommended for use in those aged

skin test developed by the US National Institute of Health and the National 

Institute of Allergy and Infectious Diseases, 41 which was later combined with 

antibody testing in Australia, has largely eliminated reactions due to previous 

immune sensitisation. Despite this, the adverse experience from earlier American 

trials, 31 in which subjects were not pre-tested, were vaccinated repeatedly or were 

inoculated with vaccines of a different composition and larger bacterial mass, 

are still quoted in the general Q fever literature as representative of the broader 

experience with whole-cell Q fever vaccines. 

The second, much less frequent, pattern has been reported in people who are 

skin and antibody test-negative at the time of vaccination and who do not have 

any immediate reaction. Some 1 to 8 months after vaccination, some vaccine 

recipients, predominantly women, have developed an indurated lesion at the 

inoculation site. At the time when the indurated lesion develops, the original 

skin test site often becomes positive, presumably indicating a late developing 

cellular immune response. These lesions are not fluctuant and do not progress 

to an abscess. Most gradually decline in size and resolve over some months 

without treatment. A few lesions have been biopsied or excised and have shown 

accumulations of macrophages and lymphocytes. 42,43 

4.15.12 Public health management of Q fever 

Q fever is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of Q fever, including 

management of cases of Q fever, should be obtained from state/territory public 




The product information for Q-Vax does not include the use of a reduced dose of 

vaccine in persons who have indeterminate results on either serological or skin 

testing. The ATAGI recommends instead that experienced Q fever vaccinators 

may elect to give reduced vaccine doses in subjects who have indeterminate 

results on either serological or skin testing. 

References 




4.16 RABIES AND OTHER LYSSAVIRUSES (INCLUDING 

AUSTRALIAN BAT LYSSAVIRUS) 


Lyssaviruses are single-stranded RNA viruses in the family Rhabdoviridae, 

genus Lyssavirus. There are 12 known species within the genus Lyssavirus, 

including the classical rabies virus and other closely related lyssaviruses such as 

the Australian bat lyssavirus (ABLV) and European bat lyssaviruses. 1 


Rabies is a zoonotic disease caused by human exposure to saliva or nerve 

tissue of an animal infected with rabies virus or other lyssaviruses. As the 

clinical disease caused by classical rabies virus and other lyssaviruses is 

indistinguishable, the term ‘rabies’ refers to disease caused by any of the known 

lyssavirus species. 2-5 Human exposure can occur via a scratch or bite that has 

broken the skin, or via direct contact with the mucosal surface of a person, 

such as nose, eye or mouth. Most human cases of rabies occur after animal 

bites – cases after animal scratches, the licking by animals of open wounds or 

contact of animal saliva with intact mucous membranes are very rare. Aerosol 

transmission has never been well documented in the natural environment. 6 There 

has been transmission of rabies virus reported following tissue transplantation 

from donors who died with undiagnosed rabies. 7 Transmission of rabies virus to 

humans through unpasteurised milk may be possible; however, rare reports of 

transmission via this route have not been confirmed. 8 

Once a person is infected, the incubation period of rabies is usually 3 to 8 weeks, 

but can range from as short as a week to, on rare occasions, several years. The 

risk of rabies is higher, and the incubation period shorter, after severe and 

multiple wounds proximate to the central nervous system (such as on the head 

and neck) and in richly innervated sites (such as the fingers). 

Rabies is almost invariably fatal. Typically, in the prodromal phase of rabies, 

which lasts up to 10 days, the patient may experience non-specific symptoms 

such as anorexia, cough, fever, headache, myalgia, nausea, sore throat, tiredness 

and vomiting. 9 Paraesthesiae and/or fasciculations at or near the site of the 

wound may be present at this stage. Anxiety, agitation and apprehension may 

also occur. Most rabies patients present with the furious or encephalitic form. 10 

In the encephalitic phase, objective signs of nervous system involvement include 

aerophobia, hydrophobia, bizarre behaviour, disorientation and hyperactivity. 

Signs of autonomic instability such as hypersalivation, hyperthermia and 

hyperventilation may occur. 10 The neurological status of the patient deteriorates 

over a period of up to 12 days, and the patient either dies abruptly from cardiac 

or respiratory arrest, or lapses into a coma. 


4.16 RABIES AND OTHER 

LYSSAVIRUSES (INCLUDING 

AUSTRALIAN BAT LYSSAVIRUS)


The epidemiology of rabies varies depending on the lyssavirus species and the 

animal host. Lyssaviruses have been found in all continents, except Antarctica. 11 

Rabies that is due to the classical rabies virus and occurs in land dwelling 

(terrestrial) mammals is present throughout much of Africa, Asia, the Americas 

and Europe, where the virus is maintained in certain species of mammals, 

particularly dogs. In countries where rabies vaccination of domestic animals is 

widespread (North America and Europe), wild animals such as raccoons and 

foxes are important reservoirs. The continual maintenance of rabies in animal 

populations in these countries is referred to as enzootic rabies. Australia, New 

Zealand, Japan, Papua New Guinea and Pacific island nations are currently free 

of rabies in terrestrial mammals. However, a country’s status can change at any 

time. For example, in 2008 on the island of Bali, Indonesia, rabies was reported 

in dogs, with cases later reported in humans. 12 Prior to this, Bali had been 

considered free of rabies, although rabies was known to occur in other areas of 

Indonesia. 13 

In some parts of the world, bats are important reservoirs of classical rabies 

as well as other lyssaviruses, with bat lyssaviruses found in areas that are 

considered free from terrestrial rabies. ABLV was first reported in bats in 1996; 

since then, two cases of fatal encephalitis caused by ABLV have been reported 

in Australians, one in 1996 and the other in 1998. 2,14 Both patients had been 

bitten by bats. Evidence of ABLV infection has since been identified in all four 

species of Australian fruit bats (flying foxes) and in several species of Australian 

insectivorous bats. 4,15-17 It should therefore be assumed that all Australian bats 

have the potential to be infected with ABLV. Different regions in Australia have 

reported higher risk of potential ABLV exposures. 18,19 ABLV has not been isolated 

from bats outside Australia. However, closely related lyssaviruses are found in 

bats in other countries. For example, European bat lyssavirus 1 and European 

bat lyssavirus 2 have been isolated in bats in some parts of Europe. Four human 

deaths from European bat lyssavirus variants have been reported in Europe, all 

with no record of prophylactic rabies immunisation. 3,5 As such, bats anywhere in 

the world should be considered a potential source of lyssaviruses and a potential 

risk for acquiring rabies, depending on the exposure. 

Information on the global occurrence of rabies can be obtained from reputable 

international authorities. 11,20,21 In addition, advice on potential lyssavirus 

exposures and their management should be obtained by contacting the relevant 

Australian state/territory health authorities (see 4.16.12 Public health management 

of lyssavirus infections below). 


4.16.4 Rabies vaccines 

• Mérieux Inactivated Rabies Vaccine – Sanofi Pasteur Pty Ltd (human 

diploid cell vaccine [HDCV]). Lyophilised powder in a monodose 

vial with 1.0 mL distilled water as diluent. Each 1.0 mL reconstituted 

dose contains ≥2.5 IU inactivated rabies virus; 100–150 µg neomycin; 

≤70 mg human serum albumin; trace of phenol red (indicator). May 

contain trace amounts of bovine gelatin and β-propiolactone. 

• Rabipur Inactivated Rabies Virus Vaccine – CSL Limited/Novartis 

Vaccines and Diagnostics Pty Ltd (purified chick embryo cell 

vaccine [PCECV]). Lyophilised powder in a monodose vial with 

1.0 mL distilled water as diluent. Each 1.0 mL reconstituted dose 

contains ≥2.5 IU inactivated rabies virus; trace amounts of neomycin, 

chlortetracycline, trometamol, β-propiolactone, monopotassium 

glutamate and amphotericin B. May contain trace amounts of bovine 

gelatin and egg protein. 

There are two inactivated rabies cell culture-derived vaccines available 

in Australia. 

The Mérieux vaccine is a lyophilised, stabilised suspension of inactivated Wistar 

rabies virus that has been cultured on human diploid cells and then inactivated 

by β-propiolactone. This human diploid cell vaccine (HDCV) is coloured offwhite, 

but after reconstitution with the diluent it turns a pinkish colour due to 

the presence of phenol red. The vaccine does not contain a preservative. 

Rabipur is a lyophilised, stabilised suspension of inactivated Flury LEP rabies 

virus that has been cultured on purified chick embryo cells and then inactivated 

by β-propiolactone. This purified chick embryo cell vaccine (PCECV) does not 

contain a preservative. 

Rabies vaccine is effective and safe when used for pre-exposure prophylaxis 

(PreP) and post-exposure prophylaxis (PEP) for rabies virus. 22,23 Although data on 

the effectiveness of rabies vaccine as prophylaxis against other lyssaviruses are 

limited, the available animal data and clinical experience support its use. 19,24-29 

4.16.5 Rabies immunoglobulin 

• Imogam Rabies Pasteurized – Sanofi Pasteur Pty Ltd (human rabies 

immunoglobulin [HRIG]). Each 1.0 mL contains IgG class human 

rabies antibodies with a minimum titre of 150 IU; 22.5 mg glycine; 

1 mg sodium chloride. Supplied in 2 mL vials. 





Human rabies immunoglobulin (HRIG) is prepared by cold ethanol fractionation 

from the plasma of hyperimmunised human donors. 


Rabies vaccine 


+2°C to +8°C. Do not freeze. 

Both rabies vaccines must be reconstituted by adding the entire contents of 

the diluent container to the vial and shaking until the powder is completely 

dissolved. Reconstituted vaccine should be used immediately. 

Human rabies immunoglobulin 



HRIG should be used immediately once the vial is opened. 


Rabies vaccine 

The dose of rabies vaccine for use in PreP and PEP is 1.0 mL, to be given by IM 

injection and is the same for infants, children and adults. 

HDCV can also be given by SC injection; however, if PCECV is inadvertently 

given via the SC route, the dose should be repeated. 

Note: Rabies vaccination administered via the intradermal (ID) route is not routinely 

used in Australia and is not recommended. The use of the ID route for rabies vaccination 

is the practitioner’s own responsibility, as rabies vaccines are not registered for use via 

this route in Australia. ID administration is particularly not recommended for postexposure 

prophylaxis. For detailed information on the restrictions that apply to the use 

of ID vaccination, if undertaken for PreP, see ‘Pre-exposure prophylaxis administered via 

the intradermal route’ below. 

Rabies vaccine should be given in the deltoid area, as rabies virus neutralising 

antibody (VNAb) titres may be reduced after administration in other sites. 

In particular, vaccine should never be given in the buttock, as failure of preexposure 

prophylaxis has been reported when given by this route. 31 In infants 

of an even more accelerated schedule for those with limited time before travel to 

a rabies-enzootic area. 

Post-exposure prophylaxis (PEP) 

In persons previously unvaccinated, the recommended schedule for postexposure 

prophylaxis (PEP) for immunocompetent persons consists of 4 doses 

of vaccine. The 1st dose of vaccine is given as soon as practicable (day 0), and 

subsequent doses are given on days 3, 7 and 14; deviations of a few days from 

this schedule are probably unimportant. 22 

The recommended schedule for PEP for previously unvaccinated 

immunocompromised persons consists of 5 doses of vaccine. The 1st dose of 

vaccine is given as soon as practicable (day 0), and subsequent doses are given 

on days 3, 7, 14 and 28; deviations of a few days from this schedule are probably 

unimportant. 

The recommended schedule for PEP for people who have been previously 

vaccinated against rabies consists of 2 doses of rabies vaccine on days 0 and 3 

(noting caveats in Figures 4.16.1 and 4.16.2). 

For more detailed information see 4.16.8 Recommendations below. 

Human rabies immunoglobulin 

When HRIG is indicated, the dose is 20 IU per kilogram of body mass and is the 

same for infants, children and adults. HRIG should be administered at the same 

time as the 1st dose (day 0) of rabies vaccine. Do not administer HRIG if 8 days 

or more have elapsed since the 1st dose of vaccine, as the HRIG may interfere 

with the immune response to the vaccine. For more detailed information see 

4.16.8 Recommendations below. 

HRIG should be infiltrated in and around all wounds using as much of the calculated 

dose as possible, and the remainder of HRIG administered intramuscularly at a 

site away from the rabies vaccine injection site. If the wounds are severe and the 

calculated volume of HRIG is inadequate for complete infiltration of all wounds 

(e.g. extensive dog bites in a young child), the HRIG should be diluted in saline 

to make up an adequate volume for the careful infiltration of all wounds. 

Wounds to fingers and hands may be small, particularly following exposures to 

bats, and infiltration of HRIG into these wounds is likely to be both technically 

difficult and painful for the recipient. 32 However, due to the extensive nerve 

supply to these sites9,10,33 it is important that as much of the calculated dose of 

HRIG as possible should be infiltrated into finger and hand wounds using either 

a 25 or 26 gauge needle. To avoid the development of a compartment syndrome, 

the HRIG should be infiltrated very gently, and should not cause the adjacent 

finger tissue to go frankly pale or white. It may be necessary to give a ring-block 

using a local anaesthetic. 32 





Interchangeability of rabies vaccines 

The World Health Organization (WHO) does not recommend interchanging 

rabies cell culture-derived vaccines (CCV), but states that, in situations where 

it is unavoidable, a PreP or PEP course can be completed with an alternative 

rabies CCV, providing the vaccine is WHO-endorsed (also termed ‘prequalified’). 

22 Various international vaccine advisory groups state that rabies 

CCV are interchangeable. This is supported by the similarities in tissue culture 

vaccine production methods as well as antibody responses and adverse 

reactions following vaccination. In one study that specifically assessed the 

interchangeability of HDCV and PCECV, 165 subjects were randomised to receive 

rabies PreP (days 0, 7 and 21–28) using either HDCV or PCECV. 34 One year 

following PreP, each group received 1 or 2 booster doses of PCECV. The booster 

dose resulted in an anamnestic response (geometric mean titre several orders of 

magnitude >0.5 IU/mL) in all subjects by day 7, independent of the vaccine that 

was used to deliver the primary course. It is expected that this response would be 

similar with other rabies CCV. 


Measures to avoid potential rabies virus and other lyssavirus (including ABLV) 

exposures 

Travellers to rabies-enzootic regions should be advised to avoid close contact 

with either wild or domestic animals; this is particularly important for 

children. 35-37 They should be advised about pre-travel (i.e. pre-exposure) rabies 

vaccination (or, if appropriate, booster doses), and on what to do should they 

be either bitten or scratched by an animal while abroad. 37-41 It is recommended 

that prior to travel, travellers be educated regarding first aid treatment for rabies 

exposures, irrespective of prior vaccination. 

Recommendations to decrease the risk of exposure to rabies include: 

• Do not allow young children to feed, pat or play with animals. The height of 

young children makes bites to the face and head more likely. 

• Avoid contact with stray dogs or cats. Remain vigilant when walking, 

running or cycling. 

• Do not carry food, and do not feed or pat monkeys, even in popular areas 

around temples or markets where travellers may be encouraged to interact 

with the monkeys. In particular, avoid focusing attention on monkeys 

carrying their young, as they may feel threatened and bite suddenly. 

In addition, contact with bats should be avoided anywhere in the world, 

including Australia. Only appropriately vaccinated and trained persons should 

handle bats. If bats must be handled, safety precautions, such as wearing 

protective gloves and clothing, should be observed. 


Pre-exposure prophylaxis for rabies virus and other lyssaviruses (including ABLV) 

PreP with rabies vaccine is recommended for: 

• persons liable to receive bites or scratches from bats (this includes bat 

handlers, veterinarians, wildlife officers and others who come into direct 

contact with bats) in any country, including Australia 

• travellers and expatriates who will be spending time in rabies-enzootic areas; 

PreP should occur following a risk assessment that takes into consideration 

the likelihood of interaction with animals and access to emergency medical 

attention 

• persons working with terrestrial animals in rabies-enzootic areas 

• research laboratory personnel working with any live lyssaviruses. 

Parents travelling with children to rabies-enzootic areas should consider PreP for 

younger children, as many children, if bitten by dogs, are often bitten on the face 

and hands because they are at an optimal height for such contact. 

Serological testing to confirm seroconversion is only necessary in certain 

circumstances (see ‘Serological testing following rabies vaccination’ below). 22 

PreP simplifies the management of a subsequent exposure because fewer doses 

of vaccine are needed and because rabies immunoglobulin (RIG) is not required 

(see ‘Post-exposure prophylaxis for rabies virus and other lyssavirus (including 

ABLV) exposures’ below). This is particularly important as RIG (human or 

equine) is often difficult to obtain in many developing countries and its safety 

may not be guaranteed. 

Pre-exposure prophylaxis administered via the intradermal route 

Intradermal PreP is not recommended because, although initial antibody titres 

may be higher, titres at 14 days are lower and wane more rapidly after ID 

administration of rabies vaccine than after either IM or SC administration. There 

may also be a slow initial immune response following exposure to rabies virus 

in those given ID rabies vaccine. 42-44 For these reasons, it is strongly recommended 

that the IM route (IM or SC if HDCV is used) be used for pre-exposure prophylaxis. (See 

also 4.16.7 Dosage and administration above.) 

However, if ID rabies PreP is considered (using a dose of 0.1 mL on days 0, 7 and 

28) it is essential that: 

• it is given by vaccine providers with not only expertise in, but also regular 

practice of, the ID technique 

• it is not administered to anyone who is immunocompromised 

• it is not administered to persons taking either chloroquine or other 

antimalarials structurally related to chloroquine (e.g. mefloquine), at either 

the time of, or within a month following, vaccination45 • any remaining vaccine is discarded at the end of the session during which the 

vial is opened (8 hours) 





• the rabies VNAb level is checked 14 to 21 days following completion of the 

pre-exposure course of ID vaccine (see ‘Serological testing following rabies 

vaccination’ below) 

• it is only used for PreP for classical rabies exposures (there are no data on the 

protection provided by ID rabies vaccination for the prevention of infection 

with other lyssaviruses, including ABLV). 

Post-exposure prophylaxis for rabies virus and other lyssavirus (including ABLV) 

exposures 

PEP for rabies virus and other lyssavirus exposures consists of prompt wound 

management, vaccine and HRIG administration. The appropriate combination 

of these components depends on the extent of the exposure, the animal source 

of the exposure, the person’s immune status and their previous vaccination 

history. The different PEP pathways are described in more detail below and PEP 

management algorithms are outlined in Figures 4.16.1 and 4.16.2. 

Types of potential rabies virus and other lyssavirus (including ABLV) exposures 

Three different categories of lyssavirus exposure are outlined in Table 4.16.1, 

based on those already described by the WHO. 22 The appropriate PEP pathway 

following each of the different exposure categories varies depending on 

whether the source of exposure was a terrestrial animal or a bat. Different 

PEP management pathways following potential bat exposures compared with 

terrestrial animal exposures are required because the risk from wounds from 

bats is often difficult to determine due to the limited injury inflicted and there 

is evidence that superficial bat exposures are more likely to result in human 

infection. 31 

An algorithm detailing the appropriate PEP pathway following potential classical 

rabies virus exposure from a terrestrial animal is provided in Figure 4.16.1; an 

algorithm for use following potential lyssavirus exposure from a bat is provided 

in Figure 4.16.2. 

Table 4.16.1: Lyssavirus exposure categories, to be used in conjunction with 

Figure 4.16.1 or 4.16.2 to determine appropriate post-exposure 

prophylaxis 

Type of exposure Description 

Category I Touching or feeding animals, licks on intact skin, as well 

as exposure to blood, urine or faeces or to an animal that 

has been dead for more than 4 hours 

Category II Nibbling of uncovered skin, minor scratches or abrasions 

without bleeding 

Category III Single or multiple transdermal bites or scratches, 

contamination of mucous membrane with saliva from 

licks, licks on broken skin 

Source: Modified from WHO 2010 22 


The relevant state/territory health authority should be contacted about any 

potential exposure sustained from a terrestrial animal in a rabies-enzootic area, or 

any potential exposure sustained from a bat anywhere in the world46 (see 4.16.12 

Public health management of lyssavirus infections below). Dogs and monkeys are the 

usual exposures in Asia, Africa and Central and South America, but exposures to 

other terrestrial mammals and bats must also be assessed for potential classical 

rabies virus transmission. If a traveller presents >10 days after being bitten or 

scratched by either a domestic dog, cat or ferret in a rabies-enzootic country, and 

it can be reliably ascertained that the animal has remained healthy (>10 days after 

the exposure), PEP is not required. Otherwise, PEP appropriate for the category 

and source of exposure (see Figure 4.16.1 or 4.16.2) should be administered, even 

if there has been a considerable delay in reporting the incident. 

The relevant state/territory veterinary or health authority should be contacted 

regarding any potential exposure to Australian bats (for ABLV) (see 4.16.12 Public 

health management of lyssavirus infections below). This includes situations where 

the category of the exposure is unsure, for example, for a person or child who 

has woken up with a bat present in a confined space but with no recollection of 

contact. If possible, and without placing others at risk of exposure, the bat should 

be kept and arrangements promptly made for testing the bat for ABLV. Following 

wound management (see below), the administration of HRIG and rabies vaccine 

can be withheld if the bat’s ABLV status will be available within 48 hours of 

the exposure. If the result will not be available within 48 hours, the appropriate 

post-exposure prophylaxis should begin as soon as is practicable, following the 

bat exposure algorithm as outlined in Figure 4.16.2. Where a bat is tested at a 

reference laboratory and later found to be negative for ABLV, then PEP for the 

person exposed to that bat can be discontinued. 

Wound management in post-exposure prophylaxis 

One of the most vital steps following a potential rabies virus or other lyssavirus 

exposure is wound management. Immediate and thorough washing of all bite 

wounds and scratches with soap and water, and the application of a virucidal 

preparation such as povidone-iodine solution after the washing, are important 

measures in the prevention of rabies. Consideration should also be given to the 

possibility of tetanus and other wound infections, and appropriate measures 

taken. Primary suture of a bite from a potentially rabid animal should be 

avoided. Bites should be cleaned, debrided and infiltrated well with HRIG, when 

indicated (see Figure 4.16.1 or 4.16.2). 

Post-exposure prophylaxis of persons who are previously unvaccinated 

Vaccine 

After performing wound management, rabies vaccine should be administered 

with or without HRIG (see ‘Human rabies immunoglobulin’ below), depending 

on the category and source of exposure, as outlined in Figure 4.16.1 or Figure 

4.16.2, and described below. 





Persons who have not previously received a complete rabies vaccine course, and 

are immunocompetent, should receive a total of 4 doses of rabies vaccine (see 

4.16.7 Dosage and administration above). Although no clinical trial has assessed the 

efficacy of rabies vaccine, the rationale supporting the use of a 4-dose schedule 

in immunocompetent persons is based on 11 studies where the immunogenicity 

of either cell culture-derived vaccine was consistently >0.5 IU/mL by day 30 

(after 4 doses) and, in a majority of participants, was >0.5 IU/mL by day 14 

(after 3 doses). Antibody responses observed after the 4th and 5th doses were 

both several orders of magnitude larger than the WHO cut-off of 0.5 IU/mL and 

were similar in value. As the additional immune boosting following a 5th dose is 

minimal, a 5th dose is not required in immunocompetent persons. 47-57 

Persons who have not previously received a complete rabies vaccine 

course and who have either an immunocompromising illness, or are taking 

immunosuppressant medications, should receive a 5-dose vaccine schedule 

(see 4.16.7 Dosage and administration above). 58-60 The rabies VNAb titre should be 

measured 14 to 21 days after the 5th dose and a further dose given if the titre is 

reported as inadequate (i.e.

Although data are limited on the effectiveness of rabies vaccine and HRIG as PEP 

against infection with lyssaviruses other than classical rabies virus, the available 

animal data and clinical experience support their use. 19,24-29 

Post-exposure prophylaxis of persons who have been previously vaccinated 

Wound management must still be carried out irrespective of prior rabies 

vaccination. 

Persons who have evidence of a previous completed recommended PreP or PEP 

regimen, or who have a previously documented adequate VNAb titre, require a 

total of 2 doses of rabies vaccine (see Figure 4.16.1 or Figure 4.16.2). This includes 

immunocompromised individuals; however, VNAb levels should be checked 

after the 2nd dose to ensure they are adequate (see ‘Serological testing following 

rabies vaccination’ below). 

Note: PreP or PEP vaccine administered via the ID route is not considered 

appropriate previous vaccination unless documentation of an adequate VNAb 

titre is available (see ‘Serological testing following rabies vaccination’ below). 

HRIG is not required and should not be administered, as its use may suppress 

the level of anamnestic response and circulating VNAb. 

In cases where a person’s vaccination status is uncertain because the 

documentation of a full course of rabies vaccine is not available, the full PEP 

regimen should be administered. 

Post-exposure prophylaxis commenced overseas 

Australians travelling overseas who are exposed to a potentially rabid animal 

(including bats from any country) may be given PEP using vaccines and 

schedules not used in Australia. In very rare circumstances, if an older nerve 

tissue-derived rabies vaccine has been administered, any doses given should be 

disregarded (see Table 4.16.2). However, it is most likely that a person vaccinated 

overseas will have received a cell culture-derived vaccine (see ‘Interchangeability 

of rabies vaccines’ in 4.16.7 Dosage and administration above). 22,34 If a person 

has received a cell culture-derived vaccine abroad, it is recommended that the 

standard post-exposure prophylaxis regimen be continued in Australia with 

either HDCV or PCECV. 

WHO-approved post-exposure rabies vaccination regimens include: 

• Zagreb (2 doses on day 0, doses on days 7 and 21: annotated as 2-0-1-1) 

• Essen (doses given on days 0, 3, 7, 14 and 28 (or 30): annotated as 1-1-1-1-1) 

• Modified Essen (doses given on days 0, 3, 7 and 14: annotated as 1-1-1-1). 

If the PEP was started overseas but HRIG or equine RIG was not given, and the 

person presents in Australia within 7 days of commencing PEP, HRIG should be 

given as soon as is practicable (and within 7 days of the 1st rabies vaccine dose). 

If the person presents in Australia 8 days or more after commencing PEP, then 

HRIG should not be administered and the appropriate number of remaining 

doses of rabies vaccine administered. 





For these and other scenarios that may arise, Table 4.16.2 outlines the most 

common PEP regimens that may be commenced overseas and the recommended 

schedule to complete PEP in Australia. 

In the case of PEP commenced overseas, every traveller should be advised to 

request a PEP certificate from the vaccination centre and to obtain or record the 

following information (preferably in English): 

• the contact details for the clinic attended (telephone and email address) 

• the batch and source of RIG used (Note: equine RIG rather than human RIG 

may be used in some countries) 

• the volume of RIG administered 

• the type of cell culture vaccine used 

• the vaccine batch number 

• the number of vials used 

• the route of vaccine administration 

• the date of RIG and/or vaccine administration. 

These details help inform decisions about PEP on return home. 


Table 4.16.2: Post-exposure prophylaxis commenced overseas and 

recommended completion in Australia 

Vaccine type/route 

administered overseas/ 

rabies immunoglobulin 

(RIG) 

Rabies vaccine schedule 

in Australia 

Nerve tissue vaccine Recommence schedule 

starting from day 0 

Unsure/unknown/poor 

documentation 

Well documented, RIG 

(equine or human) given, 

plus vaccine given either 

IM or ID 

2 vaccine doses given IM 

on day 0 

Irrespective of whether RIG 

(equine or human) was 

administered at same time 

as the 1st doses of vaccine 

Immunocompromised 

with vaccines 

administered ID 

Recommence schedule 

starting from day 0 

Align with nearest due 

dose and resume schedule 

administering vaccine IM 

(IM or SC if HDCV used) 

Give a further 2 doses; the 

1st dose on day 7 and the 

2nd dose on day 14 

Irrespective of number 

of previous doses, 

administer a 5-dose 

schedule IM (IM or SC if 

HDCV used) and check 

serology (see ‘Serological 

testing following rabies 

vaccination’ below) 

HRIG 

Category III terrestrial 

animal exposures and 

Category II and III bat 

exposures only* 

Administer HRIG if no 

RIG already given 

Do not give HRIG if 8 days 

or more since 1st dose of 

vaccine (day 0) 






No HRIG needed 




or more since 1st doses of 







* See Table 4.16.1 Lyssavirus exposure categories and Figures 4.16.1 and 4.16.2 for further information 

of PEP pathways, including HRIG administration following either a terrestrial animal or bat 

exposure. 





Figure 4.16.1: Post-exposure prophylaxis algorithm for potential exposure to 

classical rabies virus from a terrestrial animal overseas 

Potential exposure from a terrestrial animal in a rabies-enzootic area 

Category I 

• Touching or feeding animals, 

licks on intact skin 

• Exposure to blood, urine or 

faeces or to an animal that 

has been dead f . 

No prophylaxis is 

required if contact 

history is reliable 

Vaccinate § 

4 doses administered IM on 

days 0, 3, 7 and 14. Human 

rabies immunoglobulin (HRIG) 

is not indicated. 

Category II 

Nibbling of uncovered skin, 

minor scratches or abrasions 

without bleeding 

Non-immune, ‡ 

immunocompetent 

If further exposures in the future 

Treat as previously immunised and 

follow algorithm as above 

If ongoing occupational exposure 

risk – see Booster algorithm 

* If in doubt, treat as non-immune. 

Previously 

immunised* † 

Vaccinate 

Both immunocompetent and 

immunocompromised persons – 2 doses 

delivered IM on days 0 and 3. HRIG is 

not indicated. 


Category III 

• Single or multiple 

transdermal bites or scratches 

• Contamination of mucous 

membrane with saliva 

from licks 

• Licks on broken skin 

Non-immune , ‡ 


§ 

Vaccinate and administer HRIG 

HRIG is administered only once, and as 

soon as possible after the initiation of 

PEP (HRIG is not indicated beyond the 

7th day after the 1st vaccine dose on 

day 0). Rabies vaccination is 4 doses 

administered IM on days 0, 3, 7 and 14. 

† Previously immunised – documentation of a completed recommended PreP or PEP rabies 

vaccine regimen. This is irrespective of the time period since the last dose was administered. This 

may either be a completed primary pre-exposure course or post-exposure course and includes 

those where subsequent boosting has occurred, or documented rabies antibody (VNAb) titres of 

≥0.5 IU/mL. 

‡ Non-immune – person who has never received pre- or post-exposure immunisation with rabies 

vaccine, has had incomplete/inadequate primary vaccination course. 

§ Immunocompromised persons, not previously vaccinated, should receive 5 doses of vaccine 

on days 0, 3, 7, 14 and 28. Serology should be checked 14 to 21 days post dose 5 and a further 

dose offered if the result is

Figure 4.16.2: Post-exposure prophylaxis algorithm for potential exposure to 

lyssaviruses from bats in Australia or overseas 

Category I 

• Touching or feeding 

animals, licks on 

intact skin 

• Exposed to blood, 

urine or faeces or to 

an animal that has been 

dead for >4 hours 

No prophylaxis is 

required if contact 

history is reliable. 

Potential exposure from a bat (Australia or overseas) 

Category II or III 

Nibbling of uncovered skin, any scratches or abrasions with/without 

bleeding, single or multiple transdermal bites or scratches, contamination 

of mucous membrane with saliva from licks, or licks on broken skin 

* † 

Previously immunised 

Vaccinate 

Both immunocompetent 

and immunocompromised 

persons – 2 doses delivered 

IM on days 0 and 3. Human 

rabies immunoglobulin 

(HRIG) is not indicated. 

Perform serology 

i) Every 6 months for laboratory staff at risk 

ii) Every 2 years for veterinary workers, bat handlers or 

any other workers who are likely to need to handle bats. 

Give a single booster dose 

If further exposure give PEP 

as above 

Ongoing occupational exposure risk 

L 

Non-immune, ‡ 


§ § 

Vaccinate and administer HRIG 

HRIG is administered only once, and as 

soon as possible after the initiation of 

PEP (HRIG is not indicated beyond the 

7th day after the 1st vaccine dose on 

day 0). Rabies vaccination is 4 doses 

administered IM on days 0, 3, 7 and 14. 

No further action until either 

• exposure, then give PEP as above 

OR 

• time period elapses as above for 

serology – undertake VNAb serology 

* If in doubt, treat as non-immune. 

† Previously immunised – documentation of a completed recommended PreP or PEP rabies vaccine 

regimen. This is irrespective of the time period since the last dose was administered. This may either 

be a completed primary pre-exposure course or post-exposure course and includes those where 

subsequent boosting has occurred, or documented rabies antibody (VNAb) titres of ≥0.5 IU/mL. 

‡ Non-immune – person who has never received pre- or post-exposure immunisation with rabies 

vaccine or has had incomplete/inadequate primary vaccination course. 

§ Immunocompromised persons, not previously vaccinated, should receive 5 doses of vaccine on days 

0, 3, 7, 14 and 28. Serology should be checked 14 to 21 days post dose 5 and a further dose offered 

if the result is

Booster doses 

A recent WHO position paper applied a quality assessment of a moderate level 

of scientific evidence to support that cell culture-derived rabies vaccines induce 

long-term immunity of at least 10 years. 22 

The WHO states that booster doses are not required for persons who are 

travelling to, or living in, an area of high rabies risk and who have completed 

a primary course, either pre- or post-exposure, using either of the currently 

available cell culture-derived vaccines. 22 

Booster doses of rabies vaccine are recommended for immunised persons who 

have ongoing occupational exposure to lyssaviruses in Australia or overseas62 (see Figure 4.16.3). 

These include: 

• Persons who work with live lyssaviruses in research laboratories who should 

have rabies neutralising antibody titres measured every 6 months. If the titre 

is reported as inadequate (

Figure 4.16.3: Booster algorithm for persons at ongoing risk of exposure to 

either rabies or other lyssaviruses, including Australian bat 

lyssavirus (ABLV) 

Rabies or bat lyssavirus (including ABLV) booster algorithm 

Ongoing occupational exposure risk 

Perform serology 

i) 

ii) Every 2 years for veterinary workers, bat handlers or any other workers 

who are likely to need to handle bats. 

Viral neutralising antibodies 

( 

Give a single booster dose* 

If further exposure, give PEP as 

per rabies or bat lyssavirus postexposure 

algorithms 

No further action until either 

• further exposure, then give 

PEP as per rabies or bat 

lyssavirus post-exposure 

algorithms 

OR 

• time period elapses as above 

for serology – undertake 

VNAb serology 

* Immunocompromised patients’ serology should be checked 14 to 21 days post booster dose and a 

further dose offered if the result remains

to 2 years, depending on the risk of exposure, to assess the need for booster 

vaccination (see ‘Booster doses’ above). 


Rabies vaccine and HRIG are recommended in pregnant or breastfeeding women 

following a potential exposure to rabies virus, ABLV or another bat lyssavirus64,65 (see 4.16.8 Recommendations above and 3.3 Groups with special vaccination 

requirements, Table 3.3.1 Recommendations for vaccination in pregnancy). 


There are no absolute contraindications to use of either rabies vaccine or HRIG as 

post-exposure prophylaxis in persons with a potential exposure to rabies or other 

lyssaviruses, including ABLV. This is because rabies disease is almost always 

lethal. 

Persons with an anaphylactic sensitivity to eggs, or to egg proteins, should not 

receive PCECV. HDCV should be used instead. 

See also 4.16.11 Adverse events below. 


Cell culture-derived vaccines are generally well tolerated. In a large study, the 

following adverse events were reported after administration of HDCV to adults: 

sore arm (in 15 to 25% of vaccine recipients), headache (in 5 to 8%), malaise, 

nausea or both (in 2 to 5%), and allergic oedema (in 0.1%). 66 Similar adverse event 

profiles have been reported for the PCECV; these reactions occur at the same 

rates in children. 22,23,67-72 

Although anaphylactic reactions are rare (approximately 1 per 10 000 

vaccinations) following administration of HDCV, approximately 6% of persons 

receiving booster doses may experience allergic reactions. The reactions typically 

occur 2 to 21 days after a booster dose, and are characterised by generalised 

urticaria, sometimes with arthralgia, arthritis, oedema, nausea, vomiting, fever 

and malaise. 66 These reactions are not life-threatening; they have been attributed 

to the presence of β-propiolactone-altered human albumin in the implicated 

vaccines. 66 

HRIG has an excellent safety profile and, in general, no chance of immediate 

hypersensitivity reactions as is more often the case with some equine sources of 

rabies immunoglobulin. 22 

Management of adverse events 

Once initiated, rabies post-exposure prophylaxis should not be interrupted or 

discontinued because of local reactions or mild systemic reactions. Such reactions 

can usually be managed with simple analgesics. 

Because rabies disease is almost always lethal, the recommended vaccination 

regimens, in particular the PEP regimen, should be continued even if a significant 


allergic reaction occurs following a dose of rabies vaccine. Antihistamines can be 

administered in an attempt to ameliorate any subsequent reactions. 

A patient’s risk of developing either lyssavirus infection or rabies must be 

carefully considered before deciding to discontinue vaccination. 

4.16.12 Public health management of lyssavirus infections 

Classical rabies virus and ABLV virus infections in humans are notifiable diseases 

in all states and territories in Australia. 

Other lyssavirus cases that do not meet the case definition for ABLV or rabies 

virus infection are also notifiable in all states and territories in Australia. 

Detailed information regarding the management of disease from rabies and other 

lyssaviruses, including ABLV, can be found in the national guidelines for public 

health units46 (www.health.gov.au/cdnasongs). 

Both HRIG and rabies vaccine are available for PEP from the relevant state/ 

territory health authorities (see Appendix 1 Contact details for Australian, state and 

territory government health authorities and communicable disease control). 


Neither of the product information sheets for the two vaccines available in 

Australia mentions that they can be used for both PreP and PEP for ABLV 

exposures. The ATAGI instead recommends that, where indicated, either 

of the available rabies vaccines can be used as PreP or PEP as per 4.16.8 

Recommendations above. 

The product information for HDCV recommends a routine 6th dose at 90 days 

in a PEP regimen. The ATAGI recommends instead that a 4-dose schedule be 

used for PEP in immunocompetent persons. Further doses should be offered to a 

person who is immunocompromised and who has an inadequate antibody level 

following the 5-dose PEP regimen. 

The product information for HDCV also recommends a pre-exposure booster 

after a year. The ATAGI instead recommends boosters between 6 months and 

2 years for persons at continuing occupational risk (see ‘Booster doses’ in 4.16.8 


The product information for PCECV recommends a routine 5th dose at 

28 days in a PEP regimen and the product information for HDCV recommends 

a routine 5th and 6th dose at days 30 and 90, respectively, in a PEP regimen. 

The ATAGI recommends instead that a 4-dose schedule with either cell culturederived 

vaccine be used for PEP in immunocompetent persons. A 5th dose at 

day 28 should be offered to persons who are immunocompromised. Further 

doses should be offered to persons who are immunocompromised and have an 

inadequate antibody level following the 5th dose of PEP. 

References 







4.17 ROTAVIRUS 


Rotaviruses are non-enveloped RNA viruses that are classified according to 

the two surface proteins they contain: VP7, the ‘G’ glycoprotein, and VP4, the 

protease-cleaved ‘P’ protein. The G and P proteins are targets for the neutralising 

antibodies that contribute to protection against reinfection and disease. 1,2 The 

two gene segments that encode these proteins can segregate independently, and 

a binary typing system, consisting of both P and G types, has been developed. 

Rotavirus strains are most commonly referred to by their G serotype, with G1, 

G2, G3, G4 and G9 accounting for around 90% of serotypes, both globally and in 

Australia. 3,4 The most common P types found in combination with these G types 

are P1A[8] (found with all common G types except G2) and P1B[4], usually found 

in combination with G2. 5 


Rotavirus is the predominant agent of severe dehydrating gastroenteritis in 

infants and young children in both developed and developing countries. 1,2 The 

spectrum of rotavirus infection ranges from asymptomatic infection, to mild, 

watery diarrhoea of limited duration, to severe dehydrating diarrhoea with 

vomiting, fever, electrolyte imbalance, shock and death. Rotavirus infections are 

often more severe than other common causes of diarrhoea, and are more likely to 

result in dehydration and hospitalisation. 1,6 The incubation period is 1 to 3 days, 

after which illness can begin abruptly, with vomiting often preceding the onset 

of diarrhoea. 6 Up to one-third of patients have a temperature of >39°C in the first 

few days of illness. Symptoms generally resolve in 3 to 7 days. 


Rotaviruses are shed in high concentrations in the stools of infected children 

and are transmitted by the faecal–oral route, both through close person-toperson 

contact and via fomites. 7 In some instances, rotaviruses might also be 

transmitted by other modes, such as faecally contaminated food, water and 

respiratory droplets. 6,8 

Infection in early childhood is thought to be universal. Although individuals 

can be infected several times during their lives, the first infection, typically 

between 3 and 36 months of age, is most likely to cause severe diarrhoea and 

dehydration. 9,10 The degree of protection following natural infection varies. After 

a single natural infection, 40% of children are protected against any subsequent 

infection with rotavirus, 75% are protected against diarrhoea from a subsequent 

rotavirus infection, and 88% are protected against severe diarrhoea. 10 Repeat 

infections provide even greater protection. Prior to the introduction of rotavirus 

vaccines in Australia, the best available estimates were that approximately 

10 000 hospitalisations due to rotavirus occurred each year in children

age group11,12 and affecting 3.8% of all children (1 in 27) by the age of 

5 years. In addition to hospitalisations, an estimated 115 000 children 70%) in both rotavirus-specific and all-cause hospital presentations for 

gastroenteritis have been reported (Figure 4.17.1). 14-17 Emergency department 

visits for acute gastroenteritis have also declined, as have rotavirus 

notifications. 18,19 

In temperate Australia, rotavirus infections follow a seasonal pattern, with the 

peak incidence being in mid to late winter. In the northern tropical and arid 

regions, there is no consistent seasonal pattern – disease peaks are unpredictable20 and widespread epidemics cause severe strain on healthcare services. 21,22 Overall, 

Indigenous infants and children are hospitalised with rotavirus gastroenteritis 

about 3 to 5 times more commonly than their non-Indigenous peers, are younger 

at hospitalisation, and have a longer duration of stay (an average of 5 days, 

compared with 2 days for non-Indigenous infants). 12,20,21,23 

Immunocompromised children and adults, such as those with congenital 

immunodeficiency, or post haematopoietic or solid organ transplantation, are at 

increased risk of severe, prolonged and even fatal rotavirus gastroenteritis. 1,24,25 

Rotavirus is an important cause of nosocomial gastroenteritis, 26-30 and can also 

cause disease in adults, especially among those caring for children and those 

residing in aged care facilities. 1,31,32 

Figure 4.17.1: Rotavirus-coded hospitalisations per month, Australia, 2001 to 2010 17 

Number 

1200 

1000 

800 

600 

400 

200 

0 

Jan-01 Jan-02 Jan-03 Jan-04 Jan-05 Jan-06 Jan-07 Jan-08 Jan-09 Jan-10 

Month 

National Immunisation Program 


4.17 ROTAVIRUS


Two oral rotavirus vaccines are available in Australia, and their efficacy and 

safety in the prevention of rotavirus gastroenteritis have been extensively 

evaluated. 33-39 Both are live attenuated vaccines administered orally to infants, 

but the component vaccine viruses differ. The human rotavirus vaccine, 

Rotarix (GlaxoSmithKline), is a live attenuated vaccine containing one strain 

of attenuated human rotavirus (G1P1A[8] strain). Rotarix protects against 

non-G1 serotypes on the basis of other shared epitopes. A pentavalent vaccine, 

RotaTeq (CSL Limited/Merck & Co Inc), contains five human–bovine rotavirus 

reassortants with the human serotypes G1, G2, G3, G4 and P1A[8] and the bovine 

serotypes G6 and P7. 

In middle- and high-income countries, a course of vaccination with either Rotarix 

or RotaTeq prevents rotavirus gastroenteritis of any severity in approximately 

70% of recipients and prevents severe rotavirus gastroenteritis and rotavirus 

hospitalisation for 85 to 100% of recipients for up to 3 years. 33,34,40,41 Vaccination 

is also highly effective in preventing emergency department and clinic/GP 

visits. 33,40 Overall, in pre-market clinical trials, rotavirus vaccination prevented 

around half (42–58%) of hospital admissions for acute gastroenteritis of any 

cause in young children, suggesting that rotavirus is responsible for more 

gastroenteritis than detected using routine testing and admission practices. 33,34,40 

post-marketing studies in the United States and Australia have confirmed high 

vaccine effectiveness and impressive reductions in both rotavirus-coded and allcause 

gastroenteritis hospitalisations. 15,19,42-46 Reductions have also been observed 

in age groups not eligible for vaccination, suggesting that herd protective effects 

are also likely to exist for rotavirus vaccines. 15,19,45 

Although more modest estimates of efficacy have been reported in resource-poor 

settings, 36-38,47 post-marketing evaluation in the middle income countries Mexico 

and Brazil have revealed substantial reductions in diarrhoea-related mortality 

since vaccine introduction. 48,49 Studies of Rotarix during consecutive epidemics in 

Central Australia gave generally lower and wide-ranging vaccine effectiveness 

estimates, which require further investigation. 46,50 Considering the uniqueness 

of the remote Australian setting, these results should not be extrapolated to 

elsewhere in Australia, where the weight of evidence indicates a substantial 

reduction in the burden of rotavirus disease following vaccine introduction. To 

date, there has been no convincing evidence of important differences between the 

two vaccines with regard to protective efficacy against different serotypes. 33,34,39 

RotaShield, a tetravalent rhesus-reassortant vaccine, which was licensed in the 

United States (but not elsewhere) in 1998–99, was subsequently associated with 

intussusception (IS, an uncommon form of bowel obstruction in young children) 

in approximately 1 in 10 000 vaccine recipients. 51 The pathogenesis of RotaShieldassociated 

IS has not been determined. The greatest risk of IS occurred within 3 

to 14 days after the 1st dose, with a smaller risk after the 2nd dose. 51,52 There is 

evidence suggesting that when the 1st dose of RotaShield was given at >3 months 


of age, the risk of IS was increased. 52 The current rotavirus vaccines (Rotarix and 

RotaTeq) differ in composition to RotaShield, which was more reactogenic. 53-55 

The large-scale safety studies of Rotarix and RotaTeq included approximately 

140 000 infants, and found the risk of IS in vaccine recipients to be similar to that 

of placebo recipients, and less than that estimated for RotaShield. 33,34 A metaanalysis 

of clinical trial data also did not find evidence of an increased risk of 

IS among vaccine recipients. 39 The clinical trials of Rotarix and RotaTeq limited 

administration of the 1st dose of vaccine to infants under 14 and 12 weeks of age, 

respectively, and did not give subsequent doses to infants beyond 24 weeks for 

Rotarix and 32 weeks for RotaTeq. 33,34 There are no data from clinical trials on 

the use of rotavirus vaccines given outside the recommended dosing age ranges. 

While clinical trials excluded an association between Rotarix or RotaTeq and IS 

of the magnitude associated with RotaShield, post-marketing studies in Australia 

and in Mexico indicate that a smaller increase in the absolute risk of IS might 

exist, particularly post dose 1 (see 4.17.11 Adverse events below). 56,57 

Vaccine viruses replicate in the intestinal mucosa and can be shed in the stool of 

vaccine recipients, particularly after the 1st dose. Vaccine virus shedding is more 

common with Rotarix and is detected in the stool a week after vaccination in up 

to 80% of 1st dose recipients, and in up to 30% of 2nd dose recipients. 58,59 RotaTeq 

is only shed after the 1st dose (in up to 13% of recipients). 33 In one study of 80 

sets of twins, transmission of Rotarix was observed to occur from 15 vaccinated 

infants to their unvaccinated twin, 60 indicating that transmission of vaccine virus 

to unvaccinated contacts is likely to occur, but the clinical implication of this has 

not been studied (see 4.17.10 Precautions below). 

Adventitious DNA fragments of porcine circoviruses have been detected in both 

Rotarix and RotaTeq vaccines. However, porcine circoviruses have never been 

shown to cause illness in humans and are considered non-pathogenic. 

• Rotarix – GlaxoSmithKline (live attenuated RIX4414 human rotavirus 

strain, type G1P1A[8]). Each 1.5 mL monodose pre-filled oral 

applicator or squeezable tube contains ≥10 6.0 cell culture infectious 

dose 50% (CCID 50 ) of the RIX4414 strain; di-sodium adipate; 

Dulbecco’s Modified Eagle Medium; sterile water. Manufacture 

involves exposure to bovine-derived material. 

• RotaTeq – CSL Limited/Merck & Co Inc (live attenuated human– 

bovine reassortant rotavirus strains, types G1, G2, G3, G4 and 

P1A[8]). Each 2.0 mL monodose pre-filled dosing tube contains a 

minimum dose level of at least 2.0 x 10 6 infectious units of each of 

the rotavirus reassortants G1, G2, G3, G4 and P1A[8]; sodium citrate; 

sodium phosphate monobasic monohydrate; sodium hydroxide; 

polysorbate 80; cell culture medium. Manufacture involves exposure 

to bovine-derived material. 


4.17 ROTAVIRUS





Rotavirus vaccines are for oral administration only. Under no circumstances 

should rotavirus vaccines be injected. 

Rotarix is recommended for use in a 2-dose course in infants and upper age 

limits apply; see Table 4.17.1. The liquid formulation is presented as a clear, 

colourless liquid contained within an oral applicator (syringe-type applicator 

with a plunger stopper or a squeezable tube). The 1.5 mL dose of vaccine should 

be administered orally from the oral applicator onto the inside of the infant’s 

cheek. Rotarix does not require reconstitution or dilution. 

RotaTeq is recommended for use in a 3-dose course in infants and upper 

age limits apply; see Table 4.17.1. It is supplied in a container consisting of a 

squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct 

oral administration of the 2 mL dose onto the inside of the infant’s cheek. RotaTeq 

does not require reconstitution or dilution. RotaTeq is a pale yellow, clear liquid 

that may have a pink tint. 

There are limited data available on the safety of administering higher than 

the recommended dose of rotavirus vaccines or the efficacy of a partially 

administered dose(s). If most of an oral rotavirus vaccine dose has been spat 

out or vomited within minutes of administration, a single repeat dose can be 

administered during the same visit. If an infant regurgitates or vomits only a 

small part of a vaccine dose, it is not necessary to repeat the dose. Therefore, the 

regurgitated (and incomplete volume) dose is still considered as the valid dose. 


Rotavirus vaccines can be co-administered with other vaccines included on the 

NIP schedule at 2 and 4 months of age (Rotarix) or 2, 4 and 6 months of age 

(RotaTeq). The available evidence from clinical trials suggests co-administration 

of oral rotavirus vaccines is safe and effective and does not interfere with 

the immune response to other vaccine antigens (DTPa, Hib, IPV, hepB, and 

pneumococcal conjugate vaccines). 58,59,62 

There are no restrictions on the timing of administration of any other live 

vaccines in relation to rotavirus vaccines, including BCG or oral poliomyelitis 

vaccine (OPV), for example, in infants who have received OPV overseas. Delay of 

rotavirus vaccination for 4 weeks following vaccination with BCG or vice versa is 

not necessary. 


Interchangeability of rotavirus vaccines 

Completion of a course of rotavirus vaccine should be with vaccine from the 

same manufacturer whenever possible. There are no studies that address the 

interchangeability of the two available rotavirus vaccines. However, if either 

dose 1 or 2 of vaccine is given as RotaTeq, a 3rd dose of either rotavirus vaccine 

should be given, provided that the upper age limit and inter-vaccine interval, as 

defined in Table 4.17.1, are met. 


Infants 

Administration of a course of oral rotavirus vaccination is recommended for 

all infants in the first half of the 1st year of life. Vaccination of older infants and 

children is not recommended as there are theoretical concerns regarding use in 

older age groups (see 4.17.4 Vaccines above). Vaccination should occur at either 2 

and 4 months of age (Rotarix), or 2, 4 and 6 months of age (RotaTeq), according 

to the following schedules and upper age limits (see Table 4.17.1). The 1st dose of 

either rotavirus vaccine can be given as early as 6 weeks of age, where necessary 

(see Table 4.17.1). If the 1st dose is given at 6 weeks of age, the next scheduled 

rotavirus vaccine dose(s) should still be given according to the age limits 

specified for dosing in Table 4.17.1 below. 

Rotarix (human monovalent rotavirus vaccine) 

The vaccination course of Rotarix consists of 2 doses, at 2 and 4 months of age. 

The 1st dose should be given between 6 and 14 weeks of age (i.e. prior to turning 

15 weeks old), and the 2nd dose should be given by 24 weeks of age (i.e. prior to 

turning 25 weeks old). The interval between the 2 doses should not be less than 

4 weeks. 

RotaTeq (pentavalent human–bovine reassortant rotavirus vaccine) 

The vaccination course of RotaTeq consists of 3 doses, at 2, 4, and 6 months of age. 

The 1st dose should be given between 6 and 12 weeks of age (i.e. prior to turning 

13 weeks old), and all doses should be given by 32 weeks of age (i.e. prior to 

turning 33 weeks old). The interval between doses should be at least 4 weeks. 


4.17 ROTAVIRUS

Table 4.17.1: Upper age limits for dosing of oral rotavirus vaccines 

Rotarix 

(GlaxoSmithKline) 

RotaTeq (CSL 

Limited/Merck 

& Co Inc) 

Doses Age of 

routine oral 

administration 

2 oral doses 

(1.5 mL/dose) 

3 oral doses 

(2 mL/dose) 

2 and 

4 months 

2, 4 and 

6 months 


Recommended age limits 

for dosing 

1st 

dose 

6–14* 

weeks 

6–12 † 

weeks 

2nd 

dose 

10–24* 

weeks 

10–32 † 

weeks 

3rd 

dose 

Minimum 

interval 

between 

doses 

N/A 4 weeks 

14–32 † 

weeks 

4 weeks 

* The upper age limit for receipt of the 1st dose of Rotarix is immediately prior to turning 

15 weeks old, and the upper age limit for receipt of the 2nd dose is immediately prior to turning 

25 weeks old. 

† The upper age limit for receipt of the 1st dose of RotaTeq is immediately prior to turning 

13 weeks old. The 2nd dose of vaccine should preferably be given by 28 weeks of age to allow 

for a minimum interval of 4 weeks before receipt of the 3rd dose. The upper age limit for the 3rd 

dose is immediately prior to turning 33 weeks old. For infants presenting for their 2nd dose after 

reaching 29 weeks of age, a 2nd and final dose can be given, provided the upper age limit of 

32 weeks (immediately prior to turning 33 weeks old) has not been reached. 

For infants in whom the 1st dose of rotavirus vaccine is inadvertently 

administered at an age greater than the suggested cut-off (i.e. after the 14th week 

of age for Rotarix or the 12th week of age for RotaTeq), the remaining vaccine 

doses should be administered as per the schedule, providing the minimum 

interval between doses can be maintained within the recommended age limits 

for subsequent doses. The timing of the 1st dose should not affect the safety and 

efficacy of the 2nd and 3rd doses. 6 Infants who develop rotavirus gastroenteritis 

before receiving the full course of rotavirus vaccination should still complete 

the full 2- or 3-dose schedule (dependent on the brand of vaccine), because one 

rotavirus infection only provides partial immunity. 6 

Older infants 

Vaccination of older infants, children or adults is not recommended. Infants 

should commence the course of rotavirus vaccination within the recommended 

age limits for the 1st dose and doses should not be given beyond the upper age 

limits for the final dose of the vaccine course (see ‘Infants’ above). The incidence 

of severe rotavirus infection decreases with increasing age and the benefit and 

safety profile of rotavirus vaccination in older infants and children has not been 

established. 

Preterm infants 

Vaccination of preterm infants using either rotavirus vaccine is indicated at a 

chronologic age (without correction for prematurity) of at least 6 weeks, if the 

infant is clinically stable. Preterm infants (born at

gestational age; median 34 weeks) who experienced rates of adverse events after 

vaccination similar to matched placebo recipients. 6 Efficacy against rotavirus 

gastroenteritis of any severity appeared comparable to efficacy in full-term 

infants (73%; 95% CI: –2 to 95%). 64 These conclusions would also be expected 

to apply to Rotarix vaccine, which appears safe and immunogenic in preterm 

infants. 65 If standard infection control precautions are maintained, administration 

of rotavirus vaccine to hospitalised infants, including hospitalised preterm 

infants, would be expected to carry a low risk for transmission of vaccine viruses. 

See also 4.17.10 Precautions below for other special risk groups and hospitalised 

infants. 


There are no restrictions on the infant’s consumption of food or liquid, including 

breast milk, either before or after vaccination with either rotavirus vaccine. 6,62 

Infants living in households of pregnant women can receive rotavirus vaccines. 

Most pregnant women will have pre-existing immunity to rotavirus, but 

protection from transmission of wild-type infection through the vaccination of 

infant contacts may benefit adults, including pregnant women, and outweighs 

any theoretical concern regarding exposure to vaccine viruses. 


The contraindications to rotavirus vaccines are: 

• anaphylaxis following a previous dose of either rotavirus vaccine 

• anaphylaxis following any vaccine component 

• previous history of intussusception or a congenital abnormality that may 

predispose to IS 

The risk of recurrence of IS unrelated to rotavirus vaccination is in the order 

of 10%. 66 In addition, certain congenital malformations affecting the gut 

(e.g. Meckel’s diverticulum) increase the risk of IS. Because of the possible 

association of rotavirus vaccination with an increased risk of IS (see 4.17.11 

Adverse events below), it is considered prudent to withhold administration of 

rotavirus vaccines to an infant with a previous history of IS or with a known 

uncorrected congenital malformation associated with increased risk of IS. 

• severe combined immunodeficiency (SCID) in infants 

Case reports from the United States67-69 indicate prolonged vaccine virusassociated 

gastrointestinal disease following receipt of rotavirus vaccines 

among infants with SCID. Because these infants are unlikely to generate a 

protective immune response to vaccination and because of potential harm, 

rotavirus vaccines are contraindicated for infants with SCID. For infants 

with less severe forms of immunocompromise, the risk of vaccine-associated 

disease is likely to be less than the risk of natural infection (see 4.17.10 

Precautions below). 


4.17 ROTAVIRUS


Infants with acute gastroenteritis 

Infants with moderate to severe acute gastroenteritis should not be vaccinated 

until after recovery from their acute illness. Infants with mild gastroenteritis 

(including mild diarrhoea) can be vaccinated. The use of rotavirus vaccines has 

not been studied in infants with acute gastroenteritis. 

Infants with moderate to severe illness 

As with other vaccines, infants with a moderate to severe illness should be 

vaccinated after recovery. In addition to the factors mentioned above, this 

avoids superimposing potential adverse events related to vaccination with the 

concurrent illness. 

Infants with underlying conditions predisposing to severe rotavirus 

gastroenteritis 

Conditions predisposing to severe or complicated rotavirus gastroenteritis 

include metabolic disorders and chronic gastrointestinal disease, such as 

Hirschsprung’s disease, malabsorption syndromes or short gut syndrome. 1 

Data on the safety of live rotavirus vaccines among such infants is limited. In 

one report, RotaTeq was reported to be tolerated in 8 of 9 infants with highoutput 

ileostomies, while 1 infant experienced an increase in ileostomy losses. 70 

However, because of the greater risk of serious rotavirus disease, the benefits 

from vaccination are expected to outweigh the risk in these infants. 

Infants who are immunocompromised 

There are theoretical concerns that vaccine-associated gastrointestinal disease 

could occur in immunocompromised infants who receive rotavirus vaccines, and 

infants with the most severe forms of immunocompromise (SCID) should not 

receive rotavirus vaccine (see 4.17.9 Contraindications above). However, the risk 

for those infants with less severe immunocompromise may be less than the risk 

from natural infection. The risks and benefits of vaccination should be considered 

in the context of the infant’s specific immunocompromise with appropriate 

specialist advice6 (see 3.3.3 Vaccination of immunocompromised persons). 

Rotavirus vaccines have been administered to HIV-infected infants in clinical 

trial settings. 36-38 Specific data on the safety and efficacy of rotavirus vaccines in 

these infants are limited, but suggest that the vaccines are safe and immunogenic 

in HIV-infected, but clinically stable, children. 71,72 (See also 3.3.3 Vaccination 

of immunocompromised persons and Table 3.3.4 Categories of immunocompromise 

in HIV-infected persons, based on age-specific CD4 + counts and percentage of total 

lymphocytes.) There are no data on the use of rotavirus vaccines in infants born to 

women who have received immunosuppressive therapy in pregnancy (see ‘Use 

of immunosuppressive therapy during pregnancy’ in 3.3.2 Vaccination of women 

who are planning pregnancy, pregnant or breastfeeding, and preterm infants). 


Infants living in households with people who are immunocompromised 

Infants living in households with immunocompromised persons should be 

vaccinated. In general, immunocompromised household members are afforded 

protection by vaccination of young children in the household and this is 

considered to outweigh the risk of transmitting vaccine virus shed in stools to the 

immunocompromised household member. However, there have been no studies 

to specifically address this question. 6 Hand washing and the careful disposal of 

soiled nappies are likely to minimise any risk of vaccine transmission to other 

household members. (See also 3.3.3 Vaccination of immunocompromised persons.) 

Recent administration of antibody-containing blood products 

Infants who have recently received antibody-containing blood products and are 

at an eligible age should be vaccinated. The interval between vaccination and 

receipt of the blood product should be as long as possible, but without delaying 

administration of vaccine beyond the suggested age limits for dosing (as per 

Table 4.17.1 above). This recommendation for maximising the interval between 

receipt of antibody-containing blood products and rotavirus vaccination is based 

on theoretical concern that passively acquired antibody to rotavirus may interfere 

with vaccine immunogenicity. 6 

Hospitalised infants 

Administration of rotavirus vaccine to hospitalised infants, including premature 

infants, is likely to carry a low risk for transmission of vaccine viruses if 

standard infection control precautions are maintained. Provided that the infant 

is medically stable, vaccination should not be delayed, particularly if the delay 

would result in an infant being beyond the upper age limit for vaccination (see 

4.17.7 Recommendations above). If a recently vaccinated child is hospitalised for 

any reason, no precautions other than routine standard precautions need be 

taken to prevent the spread of vaccine virus in the hospital setting. 


Intussusception 

Although clinical trials of the two available vaccines did not find an association 

between vaccination and intussusception (IS) 39 (see 4.17.4 Vaccines above), one 

post-marketing study in Australia found evidence of a 4- to 5-fold increase in 

the risk of IS in the 7 days following the 1st dose of either Rotarix or RotaTeq. 56 

However, no overall increase in the risk of IS was detectable over the first 

9 months of life. 56 A similar apparent increase in risk for IS following the 1st dose 

of Rotarix has been observed in Mexico, and a smaller increase after the 2nd dose 

of Rotarix in Brazil. 57 A study in the United States found no increased risk of IS 

following RotaTeq; however, the study was limited by small numbers, which 

reduced power to determine a low range risk increase. 73 A subsequent Australian 

study estimated the increased risk of IS to be approximately 9-fold in the first 


4.17 ROTAVIRUS

7 days after dose 1, and 2-fold in the first 7 days after dose 2 of either vaccine. 74 

The baseline risk of intussusception for Australian infants is around 80 cases per 

100 000 infants. 75 The increased risk of IS following rotavirus vaccination, from 

the most recent Australian study, is estimated as approximately 6 additional 

cases of intussusception among every 100 000 infants vaccinated, or 18 additional 

cases per year in Australia. 74 This estimate assumes that infants in which 

an episode of IS occurs shortly after vaccination would not have otherwise 

experienced a ‘natural’ episode of intussusception; however, this cannot be 

determined from current data. Importantly, studies from both Australia14-17 and 

overseas57 have demonstrated the substantial impact of vaccination in preventing 

rotavirus morbidity and mortality (see also 4.17.3 Epidemiology above). Rotavirus 

vaccines continue to be recommended for use on the basis of this positive benefit 

to risk profile. 76 Immunisation providers should inform parents and carers of the 

rare risk of intussusception and how to be alert for the signs and symptoms of 

the condition. 

Rotavirus vaccine should not be given to an infant who has had a confirmed 

intussusception because there may be an increased risk of the condition recurring 

(see 4.17.9 Contraindications above). 

Other adverse events 

No significant increase in post-vaccination vomiting, diarrhoea or fever has 

been reported during follow-up of several thousand recipients of Rotarix 

compared to those who were unvaccinated. 39,77 Detailed follow-up of 11 700 

recipients of RotaTeq or placebo reported no increase in fever or irritability in 

the week after vaccination among vaccinated infants, but a small increase in 

the incidence of vomiting (7% versus 5%) and diarrhoea (10% versus 9%). 78 

Vomiting and diarrhoea have not emerged as important adverse events following 

immunisation in post-marketing surveillance of rotavirus vaccines. 

Infants who report an episode of diarrhoea or vomiting following vaccination 

should still receive subsequent rotavirus vaccine doses, as required and age 

eligible. The potential causes of diarrhoea/vomiting following vaccination 

include: gastroenteritis unrelated to rotavirus vaccination or infection (e.g. 

another viral agent); natural rotavirus infection (as vaccination is neither 

immediately protective nor 100% protective against all disease); or symptoms 

from vaccine virus replication (less likely). If rotavirus is detected by routine stool 

testing on a recently vaccinated infant, a positive test result can represent either 

natural infection or vaccine virus (as vaccine virus shedding occurs commonly 

after vaccination (see 4.17.4 Vaccines above). Specific testing is required to 

differentiate between vaccine virus and natural infection; however, this is rarely 

clinically indicated. 



The product information for Rotarix states that the vaccine should not be 

administered to subjects with any chronic gastrointestinal disease. The ATAGI 

recommends instead that pre-existing chronic gastrointestinal disease is not a 

contraindication to rotavirus vaccination, with the exception of those conditions 

that may predispose to IS (see 4.17.9 Contraindications and 4.17.10 Precautions 

above). 

The product information for RotaTeq states that in the event that a dose of 

vaccine is spat out or vomited post vaccination, a replacement dose should not 

be given. The ATAGI recommends instead that if most of a dose is spat out or 

vomited then a single replacement dose may be given (see 4.17.6 Dosage and 

administration above.) 

References 




4.17 ROTAVIRUS

4.18 RUBELLA 


Rubella is an enveloped togavirus, genus Rubivirus. The virus has an RNA 

genome and is closely related to group A arboviruses, but does not require 

a vector for transmission. It is relatively unstable, and is inactivated by lipid 

solvents, trypsin, formalin, extremes of heat and pH, and light. 1 


Rubella is generally a mild and self-limiting infectious disease, spread 

from person to person by respiratory secretions, possibly including aerosol 

transmission. 1,2 It causes a transient, generalised, erythematous, maculopapular 

rash; lymphadenopathy involving the post-auricular and sub-occipital glands; 

and, occasionally, arthritis and arthralgia. Other complications, such as 

neurological disorders and thrombocytopenia, may occur but are rare. Clinical 

diagnosis is unreliable since the symptoms are often fleeting and can be caused 

by other viruses; in particular, the rash is not unique to rubella and may be 

absent. 1,2 Up to 50% of rubella virus infections are subclinical or asymptomatic. 1 

A history of rubella should, therefore, not be accepted without serological 

evidence of previous infection. 1 The incubation period is 14 to 21 days, and the 

period of infectivity is from 1 week before until 4 days after the onset of the rash. 2 

Rubella infection in pregnancy can result in fetal infection, causing congenital 

rubella syndrome (CRS) in a high proportion of cases. Up to 90% of infants 

born to women who had rubella infection in the first trimester of pregnancy 

have abnormalities (often multiple) characteristic of CRS. 3-5 The risk of damage 

declines to 10 to 20% by 16 weeks gestation. After this stage of pregnancy, 

fetal damage is rare but has been reported up to 20 weeks gestation. 3 The 

characteristics of CRS include intellectual disabilities, cataracts, deafness, cardiac 

abnormalities, intrauterine growth retardation, and inflammatory lesions of 

the brain, liver, lungs and bone marrow. 3 Any combination of these defects 

may occur, but defects that commonly occur alone following infection after 

the first 8 weeks of pregnancy are deafness and pigmentary retinopathy. Some 

infected infants may appear normal at birth, but defects, especially sensorineural 

deafness, may be detected later. 6 

Rubella infection has been reported in some persons who already have either 

natural or vaccine-induced antibody. 3 Occasional cases of CRS after reinfection in 

pregnancy have been documented. However, fetal damage is very rare in cases of 

infection in women in whom antibody has previously been detected. 4,7-9 


Evidence suggests that endemic rubella is well controlled in Australia. 10 The 

incidence of rubella has fallen rapidly since vaccine registration, and notifications 

of rubella have been low since high vaccine coverage was achieved with the 

National Measles Control Campaign in late 1998 and then maintained. 10 Since 


2003, rubella notifications in Australia have been less than 0.3 per 100 000. There 

has been a shift in the age distribution of cases, with comparatively more cases 

seen in older age groups, particularly the 25–29 years age group. 10 

Rubella vaccines have been registered in Australia since 1970, and mass 

vaccination of schoolgirls commenced in 1971. 1,11 Non-pregnant, seronegative 

adult women were also vaccinated. These programs were successful and there 

was a significant reduction in the incidence of CRS from 1977. 12-14 Successful 

vaccination campaigns and high vaccination coverage resulted in no cases of 

congenital rubella syndrome occurring in infants of Australian-born mothers 

between 1998 and 2002. However, 5 cases resulting from infection acquired 

outside of Australia were reported during this time. 15 In 2003, 2 cases of CRS 

occurred in Australian-born mothers from infection that occurred in Australia, 16 

which reinforces the need for high vaccination coverage of women of childbearing 

age. Between 2004 and 2008, 2 confirmed cases of CRS were reported in 

Australia, in children whose mothers were born outside Australia. 17-19 

There has also been a significant increase in the percentage of pregnant women 

immune to rubella (e.g. in New South Wales from 82% in 1971 to 96% in 1983). 20 

Based on a study conducted in Melbourne in 2000, it was estimated that only 

2.5% of women of child-bearing age in Australia were seronegative. 21 However, 

susceptibility was higher among certain groups of women, particularly overseasborn 

women (see ‘Women of child-bearing age, including post-partum women’ 

in 4.18.7 Recommendations below). 21 

Young adult males may not be immune to rubella, because they did not receive 

a measles-mumps-rubella (MMR) vaccine. 22 The MMR vaccination program for 

all adolescents replaced the rubella program for girls in 1993/94. 11 A serosurvey 

conducted in 1999 showed that only 84% of males aged 14–18 years (compared to 

95% of females) and 89% of males aged 19–49 years (compared to 98% of females) 

were immune to rubella. 22 For this reason, young adult males, as well as females, 

who do not have a documented history of receipt of 2 doses of MMR vaccine 

should be vaccinated (see 4.18.7 Recommendations below). This is both for their 

own protection and to prevent transmission of the infection in the community. 

Goals for the elimination of rubella and CRS have been set by a number of 

World Health Organization (WHO) regions, and elimination has been declared 

by the Pan American Health Organization. 23 The WHO Western Pacific Region 

has set goals for increased rubella and CRS control efforts, with a number 

of member states yet to incorporate rubella vaccination into their routine 

schedule. 24 As with elimination of measles, rubella and CRS elimination 

requires continued strengthening of immunisation and surveillance efforts, 

particularly identification of rubella virus genotypes to confirm the absence of 

an endemic strain. 25 


4.18 RUBELLA


Monovalent rubella vaccine is not available in Australia. Rubella vaccination 

is provided using either MMR or measles-mumps-rubella-varicella (MMRV) 

vaccines. Two quadrivalent combination vaccines containing live attenuated 

measles, mumps, rubella and varicella viruses (MMRV) are registered in Australia. 

A single dose of rubella vaccine produces an antibody response in over 95% of 

vaccine recipients, but antibody levels are lower than after natural infection. 3,7,8 

A 2nd dose aims to confer immunity in those who fail to seroconvert to the 1st 

dose. Vaccine-induced antibodies have been shown to persist for at least 16 years 

in the absence of endemic disease. 7,8,26,27 Protection against clinical rubella appears 

to be long-term in those who seroconvert. 3 

Combination MMRV vaccines have been shown, in clinical trials, to produce 

similar rates of seroconversion to all four vaccine components compared with 

MMR and monovalent varicella vaccines administered concomitantly at separate 

injection sites. 28-31 

Trivalent measles–mumps–rubella (MMR) vaccines 






dose 50% (TCID ) of Enders’ attenuated Edmonston measles 

50 

virus, ≥12 500 TCID of the Jeryl Lynn B level mumps virus, and 

50 

≥1000 TCID of the Wistar RA 27/3 rubella virus; sorbitol; sucrose; 

50 













Jeryl Lynn strain], rubella virus [Wistar RA 27/3 strain] and varicella- 


zoster virus [Oka strain]). Lyophilised pellet in a monodose vial with 


≥10 3.0 CCID 50 of the Schwarz measles virus, ≥10 4.4 CCID 50 of the RIT 

4385 mumps virus, ≥10 3.0 CCID 50 of the Wistar RA 27/3 rubella virus, 

and ≥10 3.3 plaque-forming units (PFU) of Oka varicella-zoster virus; 







reconstituted dose contains ≥103.0 TCID of Enders’ attenuated 

50 

Edmonston measles virus, ≥104.3 TCID of the Jeryl Lynn B level 

50 

mumps virus, ≥103.0 TCID of the Wistar RA 27/3 rubella virus, and 

50 

≥103.99 PFU of Oka/Merck varicella virus; sucrose; hydrolysed gelatin; 














The dose of Priorix (MMR) vaccine for both children and adults is 0.5 mL, to be 


The dose of M-M-R II (MMR) vaccine for both children and adults is 0.5 mL, to 

be given by SC injection. 

For children


MMR or MMRV vaccines can be given at the same time as other live attenuated 

parenteral vaccines (e.g. varicella, BCG, yellow fever) or other inactivated 

vaccines (including DTPa, hepatitis B, Hib, IPV, MenCCV, hepatitis A and 

pneumococcal conjugate vaccine), 34 using separate syringes and injection sites. 


parenteral vaccines, they should be given at least 4 weeks apart. 

If MMR vaccine is given at the same time as monovalent varicella vaccine (VV), 

they should be given using separate syringes and injection sites. MMR vaccine 

and monovalent VV should not be mixed together prior to injection. 

Separate administration of measles, mumps or rubella vaccine is not available 

as an alternative to MMR vaccine, although a monovalent varicella vaccine is 

available (see 4.22 Varicella). 

Interchangeability of MMR-containing vaccines 

In general, the two brands of MMR vaccine can be considered interchangeable, 

that is, the 2nd MMR dose does not have to be of the same brand as the 1st. The 

same principle applies to the two available MMRV vaccines, 34 although they are 

not routinely recommended in a 2-dose schedule. 


For further information on the recommendations for MMR and MMRV vaccines, 


The principal aim of rubella vaccination is to prevent congenital rubella 

syndrome by stopping the circulation of rubella virus in the community. 

Susceptible pregnant women will continue to be at risk of rubella infection in 

pregnancy until the transmission of rubella virus is interrupted by continued 

high-level coverage of rubella-containing vaccine. 

A history of rubella is not a contraindication to vaccination. Persons who 

are already immune to rubella have no increased risk of side effects from 

vaccination. 3,7 

Infants aged

children

avoid the risk of transmitting rubella to pregnant women 35 (see 3.3 Groups with 

special vaccination requirements, Table 3.3.7 Recommended vaccinations for persons at 

increased risk of certain occupationally acquired vaccine-preventable diseases). 

Women of child-bearing age, including post-partum women 

Every effort should be made to identify and immunise non-pregnant 

seronegative women of child-bearing age (see ‘Serological testing for immunity 

to rubella’ below). The following women are more likely to be seronegative to 

rubella: women born overseas (especially in Asia, Pacific islands, sub-Saharan 

Africa and South America) who entered Australia after the age of routine 

vaccination; Indigenous women living in rural and remote regions; non-English 

speaking women; women over the age of 35 years; and Australian-born Muslim 

women. 12,13,21,36-38 

Seronegative women should be given MMR vaccine and advised to avoid 

pregnancy for 28 days after vaccination. Vaccinated women should be tested 

for seroconversion 6 to 8 weeks after vaccination (see ‘Serological testing for 

immunity to rubella’ below). Women who have negative or very low antibody 

levels after vaccination should be revaccinated. However, if antibody levels 

remain low after a 2nd documented vaccination, it is unlikely that further 

vaccinations will improve this. 3 Further testing and vaccination is not usually 

warranted; however, consultation with the laboratory that performed the 

serological testing may also be helpful (see also ‘Serological testing for immunity 

to rubella’ below). Negative serology after 2 documented doses of rubellacontaining 

vaccine may represent a false negative (i.e. an antibody titre too low 

to be detected using routine commercial assays). 

Although 2 doses of MMR vaccine are routinely recommended, if rubella 

immunity is demonstrated after receipt of 1 dose of a rubella-containing vaccine, 

no further dose is required, unless indicated by subsequent serological testing 

(see ‘Serological testing for immunity to rubella’ below) or if indicated for 

protection against measles and mumps (see 4.9 Measles and 4.11 Mumps). 

Women found to be seronegative on antenatal testing for rubella immunity 

should be vaccinated after delivery and before discharge from the maternity 

unit, as discussed above. These women should be tested for rubella immunity 6 

to 8 weeks following vaccination. 1,7 (See also ‘Serological testing for immunity to 

rubella’ below.) 

Serological testing for immunity to rubella 

Serological testing for immunity to rubella after routine vaccination of children 

is not recommended. However, serological testing for rubella immunity can be 

performed in cases where a history of natural immunity or 2 doses of vaccine 

administration is uncertain. It is particularly important to ensure that women 

of child-bearing age are immune to rubella (see ‘Women of child-bearing age, 

including post-partum women’ above). 


A number of commercial assays for testing immunity to rubella are available. 

These vary according to the method used to determine the positive cut-off 

value (the WHO cut-off is 10 IU/mL, but, at present, there is no recommended 

Australian minimal level). Available data support the presumption that an 

antibody level found by use of a licensed assay to be above the standard positive 

cut-off for that assay can be considered evidence of past exposure to rubella 

virus. 7 Rubella vaccine induces immune responses that are similar in quality, but 

lesser in quantity, than those after natural disease. 3 Measurement of antibody by 

commercial assays is not a perfect correlate of protection in vaccinated persons. 3 

While on the one hand, those with low levels of vaccine-induced antibodies 

are often protected, conversely, reinfection may take place in some individuals 

with measurable antibodies. If a person is found to be rubella IgG seronegative, 

vaccination should be provided according to the recommendations above. 



information is provided. In addition, expert consultation and referral of sera to 

a reference laboratory are recommended if there is difficulty interpreting results, 

particularly for women of child-bearing age (see ‘Women of child-bearing age, 

including post-partum women’ above). 

All women of child-bearing age should be advised by a medical practitioner 

of the result of their antibody test, as it is a clinically significant test. 39 Women 

should be screened for rubella antibodies shortly before every pregnancy, or 

early in the pregnancy, or if pregnancy is contemplated, irrespective of a previous 

positive rubella antibody result. 3,14 Very occasionally, errors may result in patients 

who are seronegative being reported as seropositive. Specimens from pregnant 

women are required to be stored until the completion of the pregnancy for 

parallel serological testing if required. 40 


Rubella-containing vaccines are contraindicated in pregnant women 

(see 4.18.9 Contraindications below). Pregnancy should be avoided for 28 days 

after vaccination. 41 

MMR vaccines can be given to breastfeeding women. The rubella vaccine 

virus may be secreted in human breast milk, and rare cases of transmission of 

vaccine virus through breast milk have been reported. However, symptoms 

in the newborn have been absent or mild. 42-44 Post-partum vaccination of 

women without evidence of rubella immunity need not be delayed because of 

breastfeeding. 


There is no risk to pregnant women from contact with recently vaccinated 

persons. The vaccine virus is not transmitted from vaccinated persons to 

susceptible contacts. 1 


4.18 RUBELLA





MMR and MMRV vaccines are contraindicated in persons who have had: 

• anaphylaxis following a previous dose of any MMR-containing vaccine 



Measles-, mumps-, and rubella-containing vaccines contain live 


immunocompromised. Thus, MMR-containing vaccines are contraindicated in 

the following groups: 

• Persons immunocompromised due to HIV/AIDS. MMR vaccination of 

asymptomatic HIV-infected persons >12 months of age with an age-specific 

CD4 + count of ≥15% may be considered45-48 (see ‘HIV-infected persons’ 

in 3.3.3 Vaccination of immunocompromised persons). Since studies have not 

been performed using combination MMRV vaccines in asymptomatic HIVinfected 

persons or persons with an age-specific CD4 + count of ≥15%, it is 

recommended that only MMR vaccine (and monovalent VV, see 4.22 Varicella) 

be considered for use in this setting. 47,49-51 


immunocompromise (see 3.3.3 Vaccination of immunocompromised persons) 

• Persons receiving high-dose systemic immunosuppressive therapy, 

such as chemotherapy, radiation therapy or oral corticosteroids. MMRcontaining 






attenuated vaccines after corticosteroid therapy has been discontinued for at 

least 1 month52 (see 3.3.3 Vaccination of immunocompromised persons). 

See also 3.3 Groups with special vaccination requirements and 4.22 Varicella for more 

information. 


See also 4.18.8 Pregnancy and breastfeeding above. 

Rubella-containing vaccines are contraindicated in pregnant women. 

This is due to the theoretical risk of transmission of the rubella component of the 

vaccine to a susceptible fetus. However, no evidence of vaccine-induced CRS has 

been reported. 1 Active surveillance in the United States, the United Kingdom and 


Germany indicates that no case of vaccine-induced congenital rubella syndrome 

occurred among more than 500 women inadvertently vaccinated with rubella 

vaccine during pregnancy, whose pregnancies continued. 53 In an Iranian study 

performed after mass vaccination with a measles–rubella vaccine, 117 susceptible 

women were inadvertently vaccinated while pregnant or became pregnant 

within 3 months after vaccination. There were no CRS-related abnormalities 

among the infants born to these women. 54 Based on this evidence, the vaccine 

cannot be considered to be teratogenic, and termination of pregnancy following 

inadvertent vaccination is not indicated. 1,8 (See also 3.3.2 Vaccination of women who 

are planning pregnancy, pregnant or breastfeeding, and preterm infants.) 


For additional precautions related to MMR and MMRV vaccines, see 4.9 Measles 

and 4.22 Varicella. 






Administration of a MMR or MMRV vaccine should be delayed after 



to measles, mumps, rubella and varicella vaccination may be impaired. 7,55,56 

MMR-containing vaccines should not be given for between 3 and 11 months 

following the administration of immunoglobulin-containing blood products. 

The interval between receipt of the blood product and vaccination depends on 

the amount of immunoglobulin in each product, and is indicated in 3.3 Groups 

with special vaccination requirements, Table 3.3.6 Recommended intervals between 

either immunoglobulins or blood products and MMR, MMRV or varicella vaccination. 55 


immunoglobulin and other blood products. 


MMR or MMRV vaccines. 

MMR vaccine may be administered concomitantly with, or at any time in 


immunoglobulin does not interfere with the antibody response to vaccine. 1,3,8 



following vaccination with rubella-containing vaccines, unless the benefits 


administered within this interval, the vaccinated person should either be 


4.18 RUBELLA

evaccinated later at the appropriate time following the product (as indicated in 

Table 3.3.6), or be tested for immunity 6 months later and then revaccinated if 

seronegative. 

Rh (D) immunoglobulin (anti-D) may be given at the same time in different sites 

with separate syringes or at any time in relation to MMR vaccine, as it does not 

interfere with the antibody response to the vaccine. 





Mild adverse events such as fever, sore throat, lymphadenopathy, rash, arthralgia 

and arthritis may occur following MMR vaccination. 1,7 Symptoms most often 

begin 1 to 3 weeks after vaccination and are usually transient. 

Thrombocytopenia (usually self-limiting) has been very rarely associated with 

the rubella or measles component of MMR vaccine, occurring in 3 to 5 per 100 000 

doses of MMR vaccine administered. 7,57-59 This is considerably less frequent than 

after natural measles, mumps and rubella infections. 59 

For further information on adverse events related to MMR and MMRV vaccines, 


4.18.12 Public health management of rubella 

Rubella is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of rubella, including 

management of cases of rubella and their contacts, should be obtained from state/ 

territory public health authorities (see Appendix 1 Contact details for Australian, state 

and territory government health authorities and communicable disease control). 

Rubella-containing vaccine does not provide protection if given after exposure to 

rubella. 7 However, if the exposure did not result in infection, the vaccine would 

induce protection against subsequent infection. Normal human immunoglobulin 

(NHIG) has been shown not to be of value in post-exposure prophylaxis for 

rubella. 7 However, NHIG may be recommended in certain circumstances (see ‘Use 

of normal human immunoglobulin in pregnant women exposed to rubella’ below). 

Suspected rubella contacts 

All contacts of persons with suspected rubella infection should be identified, 

especially those who are pregnant (see ‘Pregnant women with suspected rubella 

or exposure to rubella’ below). 

Contacts >12 months of age without adequate proof of immunity should receive 

1 dose of MMR vaccine (or MMRV vaccine, if appropriate). This will not prevent 

rubella disease if already exposed. If vaccination is refused, the contact should 

avoid further contact with cases until at least 4 days after onset of the rash in the 


case. Seronegative women of child-bearing age should be vaccinated and tested 

for seroconversion 6 to 8 weeks after vaccination (see 4.18.7 Recommendations 

above). 

Exposed healthcare workers without adequate proof of immunity should be 

excluded from work for 21 days from exposure or for at least 4 days after the 

onset of rash. 60 

Testing for rubella infection 

All cases of suspected rubella infection should be laboratory tested and false 

positive results excluded (see ‘Serological testing for immunity to rubella’ in 

4.18.7 Recommendations above). 

Acute rubella infection is indicated by the presence of rubella IgM or a 4-fold or 

greater increase in rubella IgG. Rubella IgM may not appear until a week after 

clinical symptoms. Sera for testing should be taken 7 to 10 days after onset of 

illness and repeated 2 to 3 weeks later. The most recent date of potential exposure 

should be obtained, if possible, to calculate the potential incubation period. As 

some patients may have more than one exposure to a person with a rubella-like 

illness, and because exposure may occur over a prolonged period, it is important 

to ascertain the dates of the first and last exposures. 60 Testing for infection can 

also be done, particularly early in the course of a clinical illness, using virusdetection 

methods, such as nucleic acid amplification testing (PCR). 60 

Infected persons should be excluded from school/work/institution and should 

avoid contact with women of child-bearing age for at least 4 days after the onset 

of the rash. 60 

Pregnant women with suspected rubella or exposure to rubella 

All pregnant women with suspected rubella or exposure to rubella should 

be serologically tested (for IgM and IgG), irrespective of a history of prior 

vaccination, clinical rubella or a previous positive rubella antibody result (for 

more details, see ‘Testing for rubella infection’ above). Testing is essential because 

of the serious consequences of the infection, the rash of rubella is not diagnostic, 

asymptomatic infection can occur, and the diagnosis requires confirmation by 

laboratory tests. 3,7,8 In addition, infection has been reported in women who have 

previous evidence of antibody. 7 

Serologic specimens should include information regarding the date of the 

last menstrual period and the date of presumed exposure (or date of onset of 

symptoms). 60 If the woman has an antibody titre below the protective level, or a 

low level of antibodies and remains asymptomatic, a second specimen should be 

collected 28 days after the exposure (or onset of symptoms) and tested in parallel 

with the first. Alternatively, if the woman develops symptoms/signs of rubella 

infection, a second serum specimen should be tested as soon as possible. A third 

blood specimen may be required in some circumstances. 8 Testing for infection 


4.18 RUBELLA

can also be done, particularly early in the course of a clinical illness, using virusdetection 

methods, such as nucleic acid amplification testing (PCR). 60 

Pregnant women should be counselled to restrict contact with persons with 

confirmed, probable or suspected rubella for 6 weeks (2 incubation periods). 60 

Counselling of pregnant women with confirmed rubella regarding the risk to the 

fetus should be given in conjunction with the woman’s obstetric service. 

Use of normal human immunoglobulin in pregnant women exposed to rubella 

Post-exposure prophylaxis with normal human immunoglobulin (NHIG) does 

not prevent infection in non-immune contacts and is, therefore, of little value 

for protection of susceptible contacts exposed to rubella. 7 However, it may 

prolong the incubation period. If given to non-immune pregnant contacts, this 

may marginally reduce the risk to the fetus. It may also reduce the likelihood of 

clinical symptoms in the mother. In such cases, IM administration of 20 mL of 

NHIG within 72 hours of rubella exposure might reduce, but will not eliminate, 

the risk for rubella. 60 Serological follow-up of recipients is essential, and should 

continue for up to 2 months. 

There is some evidence to suggest that, in outbreak situations, pre-exposure 

NHIG may be effective in preventing infection in women who are likely to be 

pregnant, and its use may be indicated for such women with low antibody titres 

in high-risk occupations. 61 


The product information for MMR and MMRV vaccines recommends that 

women of child-bearing age should be advised not to become pregnant for 

3 months after vaccination. The ATAGI instead recommends avoiding 

pregnancy for 28 days after vaccination. 41 

For further information on MMR and MMRV vaccines, see 4.9 Measles and 

4.22 Varicella. 

References 




4.19 TETANUS 


Tetanus is caused by Clostridium tetani, a motile, non-capsulated, Gram-positive 

rod that forms endospores. Spores of the bacillus are found in manured soil and 

can enter wounds. Once in a wound site, the bacillus can grow anaerobically. 

C. tetani produces a potent protein toxin, which has two components, 

tetanospasmin (a neurotoxin) and tetanolysin (a haemolysin). 


Tetanus is an acute, often fatal, disease caused by the toxin produced by 

C. tetani. The neurotoxin acts on the central nervous system to cause muscle 

rigidity with painful spasms. The disease usually occurs after an incubation 

period of 3 to 21 days (range 1 day to several months), with a median time 

of onset after injury of 10 days. Generally, a shorter incubation period is 

associated with a more heavily contaminated wound, more severe disease 

and a worse prognosis. Generalised tetanus, the most common form of the 

disease, is characterised by increased muscle tone and generalised spasms. 

Early symptoms and signs include increased tone in the masseter muscles 

(trismus, or lockjaw), dysphagia, and stiffness or pain in the neck, shoulder 

and back muscles. Some patients develop paroxysmal, violent, painful, 

generalised muscle spasms. A constant threat during generalised spasms is 

reduced ventilation, apnoea or laryngospasm. The patient may be febrile, 

although many have no fever; mental state is unimpaired. Sudden cardiac 

arrest sometimes occurs, but its basis is unknown. Other complications include 

pneumonia, fractures, muscle rupture, deep vein thrombophlebitis, pulmonary 

emboli, decubitus ulcers and rhabdomyolysis. Death results from respiratory 

failure, hypertension, hypotension or cardiac arrhythmia. 

Tetanus is uncommon in people who have received 4 or more doses of a tetanuscontaining 

vaccine and in those who received their last dose within 10 years. 1,2 

However, cases have been reported3,4 and clinicians should consider tetanus 

when there are appropriate symptoms and signs, irrespective of the person’s 

vaccination status. A high level of diagnostic awareness of tetanus is particularly 

important in the elderly in industrialised countries, including Australia, as most 

deaths occur in people over 70 years of age, especially women, and may be 

associated with apparently minor injury. 1,2,5 

Neonatal tetanus is usually associated with generalised symptoms, and fatal 

if left untreated. It usually occurs following contamination of the umbilical 

cord stump. Neonatal tetanus was effectively eliminated in Australia and other 

developed countries over a century ago. Introduction of maternal immunisation 

during pregnancy with tetanus toxoid has seen neonatal tetanus almost 

eliminated in developing countries. 6 


4.19 TETANUS


In Australia, tetanus is rare, occurring primarily in older adults who have 

never been vaccinated or who were vaccinated in the remote past. There 

were 24 notified cases of tetanus during 2001–2007, but 156 hospitalisations 

(July 2000–June 2007) where tetanus was coded as the principal diagnosis. 5,7,8 

This discrepancy suggests under-notification. During 2001–2006, there were 

3 deaths recorded from tetanus. 5,7,8 The case-fatality rate in Australia is about 

2%. Effective protection against tetanus can be provided only by active 

immunisation. This is because the amount of tetanus toxin required to produce 

clinical symptoms is too small to induce a protective antibody response; second 

cases of tetanus in unimmunised persons have been recorded. Tetanus vaccine 

was introduced progressively into the childhood vaccination schedule after 

World War II. The effectiveness of the vaccine was demonstrated in that war; all 

Australian servicemen were vaccinated against tetanus and none contracted the 

disease. As tetanus can follow apparently trivial, even unnoticed wounds, active 

immunisation is the only certain protection. 1 A completed course of vaccination 

provides protection for many years. 


Tetanus toxoid is available in Australia only in combination with diphtheria 

and other antigens. 






Tetanus vaccination stimulates the production of antitoxin. Hence, vaccination 

does not prevent growth of C. tetani in contaminated wounds, but protects 

against the toxin produced by the organism. The immunogen is prepared by 

treating a cell-free preparation of toxin with formaldehyde, thereby converting 

it into the innocuous tetanus toxoid. Tetanus toxoid is usually adsorbed onto an 

adjuvant, either aluminium phosphate or aluminium hydroxide, to increase its 

immunogenicity. Antigens from Bordetella pertussis, in combination vaccines, also 

act as an effective adjuvant. 

Complete immunisation (a 3-dose primary schedule and 2 booster doses) induces 

protective levels of antitoxin throughout childhood and into adulthood but, by 

middle age, about 50% of vaccinated persons have low or undetectable levels. 9-11 

A single dose of tetanus toxoid produces a rapid anamnestic response in such 

persons. 12-15 







Reduced antigen formulations for adults, adolescents and children aged 

≥10 years 

• ADT Booster – CSL Limited/Statens Serum Institut (dT; diphtheriatetanus). 

Each 0.5 mL monodose vial or pre-filled syringe contains 

≥2 IU diphtheria toxoid and ≥20 IU tetanus toxoid, adsorbed onto 

0.5 mg aluminium as aluminium hydroxide. 





















glycine. 


















The dose of all tetanus-containing vaccines is 0.5 mL, to be given by IM injection. 

Do not mix DTPa- or dTpa-containing vaccines or dT vaccine with any other 

vaccine in the same syringe, unless specifically registered for use in this way. 



Tetanus toxoid is given in combination with diphtheria toxoid and acellular 

pertussis as DTPa vaccine. The recommended 3-dose primary schedule is at 2, 

4 and 6 months of age. The 1st dose can be given as early as 6 weeks of age, due 

to the high morbidity and occasional mortality associated with pertussis in very 

young infants. If the 1st dose is given at 6 weeks of age, the next scheduled doses 

should still be given at 4 months and 6 months of age (see 4.12 Pertussis). 

A booster dose of tetanus-containing vaccine, usually provided as DTPa- 

IPV, is recommended at 4 years of age, but can be given as early as 3.5 years. 

For this booster dose, all brands of DTPa-containing vaccines are considered 

interchangeable. 



Adults 

Booster vaccination 

All adults who reach the age of 50 years without having received a booster dose 

of dT in the previous 10 years should receive a further tetanus booster dose. This 

should be given as dTpa, to also provide protection against pertussis (see 4.12 

Pertussis). This stimulates further production of circulating tetanus antibodies at 

an age when waning of diphtheria and tetanus immunity is commencing in the 

Australian population. 9 Travellers to countries where health services are difficult 

to access should be adequately protected against tetanus before departure. They 

should receive a booster dose of dT (or dTpa if not given previously) if more than 

10 years have elapsed since the last dose of dT-containing vaccine. 



of a dT-containing vaccine. 

Primary vaccination 

Persons who have not received any tetanus vaccines are also likely to have 

missed diphtheria vaccination. Therefore, 3 doses of dT should be given at 

minimum intervals of 4 weeks, followed by booster doses at 10 and 20 years after 

the primary course. One of these 3 doses (preferably the 1st) should be given as 

dTpa, to also provide additional protection against pertussis. In the event that 

dT vaccine is not available, dTpa can be used for all primary doses. However, 

this is not recommended routinely because there are no data on the safety, 

immunogenicity or efficacy of dTpa in multiple doses for primary vaccination. 


vaccine requiring catch-up, see 2.1.5 Catch-up. 


Although dT or dTpa vaccines are not routinely recommended for pregnant 

women, they can be given under certain circumstances, such as for management 

of a tetanus-prone wound (see 4.19.9 Tetanus-prone wounds below) or to prevent 

pertussis in pregnant women and their newborns (see 4.12 Pertussis). 17 

dT or dTpa vaccines can be given to breastfeeding women. 



4.19.9 Tetanus-prone wounds 

The definition of a tetanus-prone injury is not straightforward, as tetanus 

may occur after apparently trivial injury, such as from a rose thorn, or with no 

history of injury. It is for this reason that all wounds other than clean, minor 

cuts are considered ‘tetanus-prone’. However, there are certain types of wounds 

that are more likely to favour the growth of tetanus organisms. These include 

compound fractures, bite wounds, deep penetrating wounds, wounds containing 


foreign bodies (especially wood splinters), wounds complicated by pyogenic 

infections, wounds with extensive tissue damage (e.g. contusions or burns) and 

any superficial wound obviously contaminated with soil, dust or horse manure 

(especially if topical disinfection is delayed more than 4 hours). Reimplantation 

of an avulsed tooth is also a tetanus-prone event, as minimal washing and 

cleaning of the tooth is conducted to increase the likelihood of successful 

reimplantation. Persons who inject drugs are also at risk of tetanus, particularly 

if skin ‘popping’ is practised. 18 Appropriate tetanus prophylaxis measures 

in wound management, including use of tetanus immunoglobulin (TIG), are 

outlined in Table 4.19.1. 

Adults who have sustained injuries deemed to be tetanus-prone (all wounds 

other than clean minor cuts) should receive a booster dose of dT if more than 

5 years have elapsed since the last dose of tetanus-containing vaccine (see 

Table 4.19.1). As an alternative to dT vaccine after a tetanus-prone wound, 

adults can receive dTpa vaccine (see 4.12 Pertussis) to also provide additional 

protection against pertussis. 19 In children

Table 4.19.1: Guide to tetanus prophylaxis in wound management 

History 

of tetanus 

vaccination 

Time since 

last dose 

Type of wound DTPa, DTPacombinations, 

dT, dTpa, as 

appropriate 


Tetanus 

immunoglobulin* 

(TIG) 

≥3 doses 10 years Clean minor 

wounds 

YES NO 

All other wounds † YES NO ‡ 

studies indicate that the adverse reactions to a single dose of dTpa are similar 

in adults and adolescents, whether administered shortly (18 months) or at a 

longer interval after a previous dose of a vaccine containing tetanus/diphtheria 

toxoids. 26-29 (See also 4.12 Pertussis.) 


Mild discomfort or pain at the injection site persisting for up to a few days is 

common. Uncommon general adverse events following dT vaccine include 

headache, lethargy, malaise, myalgia and fever. Anaphylaxis, urticaria and 

peripheral neuropathy occur very rarely. Brachial neuritis (inflammation of a 

nerve in the arm, causing weakness or numbness) has been described following 

the administration of tetanus toxoid-containing vaccines, with an estimated 

excess risk of approximately 0.5–1 in 100 000 doses in adults. 30,31 For specific 

adverse events following combination vaccines containing both tetanus and 

pertussis antigens, see 4.12 Pertussis. 

4.19.13 Public health management of tetanus 

Tetanus is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of tetanus, including 

management of cases of tetanus, should be obtained from state/territory public 



• Tetanus Immunoglobulin-VF (human; for intramuscular use) – CSL 

Limited. 160 mg/mL immunoglobulin (mainly IgG) prepared from 

human plasma containing high levels of antibody to the toxin of 

Clostridium tetani. Single vials contain 250 IU of human tetanus 

antitoxin, with the actual volume stated on the label on the vial. Also 

contains glycine. 

For information on the definition and management of tetanus-prone wounds, 

see 4.19. 9 Tetanus-prone wounds and Table 4.19.1 above. To access tetanus 

immunoglobulin (for intramuscular use for management of tetanus-prone 

wounds, or intravenous tetanus immunoglobulin for the treatment of clinical 

tetanus), contact the Australian Red Cross Blood Service (see Part 5 Passive 

immunisation). 






The product information for Infanrix IPV states that this vaccine is indicated 

for use in a 3-dose primary schedule for immunisation of infants from the 

age of 6 weeks and as a single booster dose for children ≤6 years of age who 

have previously been vaccinated against diphtheria, tetanus, pertussis and 

poliomyelitis. In addition, the ATAGI recommends that this product may 

also be used for catch-up of the primary schedule or as a booster in children 

The product information for Adacel and Boostrix states that there is no 

recommendation regarding the timing and frequency of booster doses against 

pertussis in adults; however, the ATAGI recommends that pregnant or postpartum 

women can receive a booster dose every 5 years and that other adults in 

contact with infants and/or at increased risk from pertussis can receive a booster 

dose every 10 years. 

The product information for Boostrix, Boostrix-IPV and Adacel states that 

dTpa-containing vaccine should not be given within 5 years of a tetanus 

toxoid-containing vaccine. The product information for Adacel Polio states that 

dTpa-containing vaccine should not be given within 3 years of a tetanus toxoidcontaining 

vaccine. The ATAGI recommends instead that, if protection against 

pertussis is required, dTpa-containing vaccines can be administered at any time 

following receipt of a dT-containing vaccine. 







The product information for Adacel Polio states that this vaccine is not indicated 

following a tetanus-prone wound. The ATAGI recommends instead that Adacel 

Polio can be administered following a tetanus-prone wound. 

References 




4.19 TETANUS

4.20 TUBERCULOSIS 


Tuberculosis (TB) is caused by organisms of the Mycobacterium tuberculosis 

complex (M.TB complex), which are slow-growing, aerobic, acid-fast bacilli. 

The M.TB complex consists of Mycobacterium tuberculosis, M. bovis, M. microti, 

M. canetti and M. africanum, 1 of which M. tuberculosis is the cause of almost all TB 

in Australia. 2 


As infection is usually air-borne, lung disease is the most common form of 

tuberculosis, accounting for approximately 60% of notified TB cases in Australia. 3 

Cough, fever, sweats, weight loss and haemoptysis are common symptoms 

of pulmonary TB. TB lymphadenitis is the most common extrapulmonary 

manifestation, but the disease can occur in any part of the body. Disseminated 

disease (miliary TB) and meningeal TB are more common in very young children, 

and are among the most serious manifestations of TB disease. 1 

Most persons infected with M. tuberculosis remain asymptomatic, but there is 

a 10% lifetime risk of developing clinical illness (although the risk can vary 

depending on age and immune status), sometimes many years after the original 

infection. Infants, the elderly and persons who are immunocompromised, due to 

drugs or disease or as a result of adverse socioenvironmental circumstances (e.g. 

malnutrition, alcoholism), are more prone to rapidly progressive or generalised 



The World Health Organization (WHO) declared tuberculosis a global emergency 

in 1993, and recent reports have reaffirmed the threat to human health. 5 It is 

estimated that in 2010 there were 8.8 million incident cases of TB globally. The 

majority of these cases (81%) were accounted for by 22 high-burden countries, 

which all have estimated TB incidences of greater than 40 per 100 000. 6 

Approximately 1200 cases of TB are notified to Australian health authorities 

each year. The annual notification rate for TB has been relatively stable at 

approximately 5 to 6 cases per 100 000 population since 1985. 2,3 In the southern 

states, rates among Indigenous Australians overall are comparable with rates 

among Australian-born non-Indigenous Australians; however, in some specific 

settings (e.g. in the Northern Territory, Far North Queensland and northern 

South Australia) rates are higher in Indigenous Australians3 (see 3.1 Vaccination 

for Aboriginal and Torres Strait Islander people). Most TB cases in Australia (over 

85%) occur in persons born overseas, particularly those born in Asia, southern 

and eastern European countries, Pacific island nations, and north and sub- 

Saharan Africa. The rate of TB in the overseas-born population has been slowly 

increasing over the past decade. 3 The rate of multi-drug resistant (MDR) TB in 

Australia has been low (less than 2% of notified cases); however, the proportion 


of MDR-TB cases identified has increased in recent years. 2,3,7-9 Tuberculosis in 

animals (M. bovis) has been eradicated by screening and culling programs. 10 

Patients who are immunocompromised are at high risk of developing active 

TB if they are infected with M. tuberculosis. 4,5,11 Screening programs in Australia 

concentrate on contacts of notified cases and others at increased risk of TB 

infection, including refugees and healthcare workers. 


• BCG vaccine – Sanofi Pasteur Pty Ltd (live vaccine prepared from an 

attenuated strain of Mycobacterium bovis). 1.5 mg lyophilised powder 

in a multi-dose vial with separate diluent. Reconstituted vaccine 

contains 8–32 x 10 6 colony forming units per mL and monosodium 

glutamate 1.5% w/v. May contain trace amounts of polysorbate 80. 

Reconstituted volume provides about 10 adult or 20 infant doses. 

BCG (bacille Calmette-Guérin) vaccine is a suspension of a live attenuated 

strain of M. bovis. Worldwide, there are many BCG vaccines available, but they 

are all derived from the strain propagated by the Institute Pasteur, which was 

first tested in humans in 1921. 12 BCG vaccination probably has little effect on 

preventing infection per se, or reactivation among those already infected with 

TB, so the role of BCG vaccination in preventing overall transmission is probably 

limited. 13 However, there is strong evidence that BCG vaccination in infancy 

provides greater than 70% protection against severe disseminated forms of TB 

disease in young children, including miliary TB and TB meningitis. 14-18 TB can be 

difficult to diagnose in young children and progression to disseminated TB can 

be rapid; they are therefore the primary target for the use of BCG vaccine. The 

efficacy of BCG vaccine against pulmonary disease in adults is less consistent 

and has ranged from no protection to 80% in controlled trials. 19 The greatest 

protection has been observed among skin test-negative adults in North America 

and Europe, and the lowest among skin test-positive persons in tropical 

settings. 13 The reason for the wide variation in measured effectiveness is not clear, 

but has been attributed to variability in study quality, differences in BCG strains, 

host factors such as age at vaccination and nutritional status, and differences 

in the prevalence of infection with environmental mycobacteria. The duration 

of protection following BCG vaccination has been difficult to measure because 

the interval between infection and disease may extend to decades. Benefit from 

infant vaccination has been found in studies with follow-up of up to 12 years, but 

protection is commonly thought to decline over 10 to 20 years. 13 There is evidence 

that memory responses persist for up to 10 to 50 years. 20-22 


4.20 TUBERCULOSIS

BCG vaccination has been shown to offer some protection against Mycobacterium 

leprae, the causative agent of leprosy. 23 

BCG vaccine is not used in the treatment of tuberculosis disease. BCG may be 

used as a therapeutic modality for transitional cell carcinoma of the bladder. 




BCG vaccine must be reconstituted by adding the entire contents of the diluent 


Reconstituted vaccine is very unstable and must be stored at +2°C to +8°C and 

used within one working session of 4 to 6 hours. 


The dose of BCG vaccine in newborns and infants

BCG vaccination procedures 

BCG vaccination should only be given by medical or nursing staff who are 

trained in BCG vaccination procedures. 

• Use a short (10 mm) 26–27 gauge needle with a short bevel. The risk of 

spillage can be minimised by using an insulin syringe to which the needle is 

already attached. 

• Wear protective eye-wear. The person to be vaccinated (and the parent/carer 

holding a small child being vaccinated) should also wear protective eye-wear. 

Eye splashes may ulcerate; if an eye splash occurs, wash the eye with saline 

or water immediately. 

• Identify the correct injection site. BCG vaccine should be injected into the 

skin over the region of insertion of the deltoid muscle into the humerus. This 

is just above the midpoint of the upper arm. This site is recommended to 

minimise the risk of keloid formation. By convention, the left upper arm is 

used wherever possible to assist those who subsequently look for evidence of 

BCG vaccination. 

• Stretch the skin between a finger and thumb and insert the bevel into the 

dermis, bevel uppermost, to a distance of about 2 mm. The bevel should be 

visible through the transparent epidermis. 

• If the injection is not intradermal, withdraw the needle and try again at a new 

site. A truly intradermal injection should raise a blanched bleb of about 7 mm 

in diameter with the features of peau d’orange (the appearance of orange 

peel). Considerable resistance will be felt as the injection is given. If this 

resistance is not felt, the needle may be in the subcutaneous tissues. 

Response to BCG vaccination 

In response to BCG vaccination, a small red papule forms and eventually 

ulcerates, usually within 2 to 3 weeks of vaccination. The ulcer heals with 

minimal scarring over several weeks. There may be swelling and tenderness in 

local lymph nodes. While a local reaction represents a normal response to BCG 

vaccination, more extensive local reactions are less common (see 4.20. 11 Adverse 

events below). Subjects who are given BCG vaccine despite latent or previous 

TB infection are likely to experience an accelerated response characterised by 

induration within 24 to 48 hours, pustule formation in 5 to 7 days, and healing 

within 10 to 15 days. 

Clinical trials have not shown a consistent relationship between the size of 

tuberculin reactions after BCG vaccination and the level of protection provided. 

TST is not recommended to demonstrate immunity after BCG vaccination. 28,29 


4.20 TUBERCULOSIS


BCG is not recommended for routine use in the general population, given the 

low incidence of TB in Australia and the variable efficacy reported in adults. 

However, some groups are at increased of tuberculosis and BCG vaccination 

may be warranted for these persons, based on a risk assessment. BCG should be 

specifically considered for the following groups. 

Aboriginal and Torres Strait Islander neonates30 In some parts of Australia, the incidence of TB is appreciably higher among 

Aboriginal and Torres Strait Islander people than Australian-born non- 

Indigenous Australians, and BCG is recommended for neonates living in 

those regions. State and territory guidelines should be consulted for local 

recommendations and the geographic areas where BCG vaccination of 

Aboriginal and Torres Strait Islander neonates is conducted (see Appendix 1 


communicable disease control). (See also 3.1 Vaccination for Aboriginal and Torres 

Strait Islander people.) 

Infants born in Australia to migrant parents 

TB is rare in infants and young children born in Australia, but infants born to 

parents who have migrated from countries with a high TB incidence (i.e. >40 cases 

per 100 000 population per year – see 4.20.3 Epidemiology above) may be at higher 

risk of TB exposure in their early life. 31 BCG vaccination of these infants is not 

routinely recommended because of the uncertainty of the risks and benefits. 

Children who will be travelling to high TB incidence settings 

The risk of TB disease in children travelling to countries with a high TB incidence 

(i.e. >40 cases per 100 000 population per year – see 4.20.3 Epidemiology above) 

depends on the age of the child, the duration of stay, and the TB incidence at the 

destination. Country-specific incidence data are available from the World Health 

Organization. 32 

The need for BCG vaccination should be assessed for young children, 

particularly those aged

Occupational groups 

There is some evidence that specific occupational groups are at increased risk of 

TB, including embalmers, and healthcare workers likely to encounter patients 

with TB (e.g. chest clinic staff) or those involved in conducting autopsies. Due 

to the limited evidence of benefit of BCG vaccination in adults and interference 

of vaccination with interpretation of TST, routine BCG vaccination of persons 

within these occupations is not recommended. In occupational settings, TB 

prevention and control should be focused around infection control measures, 

employment-based TST screening and therapy for latent TB infection. However, 

BCG vaccination should be considered for TST-negative healthcare workers who 

are at high risk of exposure to drug-resistant TB, due to the difficulty in treating 

drug-resistant infection. 


BCG vaccine is contraindicated in pregnant women. 

BCG vaccine can be given to breastfeeding women. 




BCG is a live vaccine and its use is contraindicated in the following groups: 

• Persons with known or suspected HIV infection, 33 even if asymptomatic 

or with normal immune function, because of the risk of disseminated BCG 


• Persons treated with corticosteroids or other immunosuppressive therapy, 

including monoclonal antibodies against tumour necrosis factor-alpha (TNFalpha) 

(e.g. infliximab, etanercept, adalimulab). Infants born to mothers 

treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies) 

in the third trimester of pregnancy frequently have detectable antibodies for 

several months and they should not be vaccinated36-38 (see also 3.3 Groups with 

special vaccination requirements). 

• Persons with congenital cellular immunodeficiencies, including specific 

deficiencies of the interferon-gamma pathway. 

• Persons with malignancies involving bone marrow or lymphoid systems (see 

also 3.3 Groups with special vaccination requirements). 

• Persons with any serious underlying illness, including severe malnutrition. 

• Pregnant women (BCG vaccine has not been shown to cause fetal damage, 

but use of live vaccines in pregnancy is not recommended). 

• Persons who have previously had TB or a large (≥5 mm) reaction to a 

tuberculin skin test. 


4.20 TUBERCULOSIS


For those who would otherwise be candidates for BCG, vaccination should be 

deferred in the following groups: 

• Neonates who are medically unstable, until the neonate is in good medical 

condition and ready for discharge from hospital. 

• Infants born to mothers who are suspected or known to be HIV-positive, 

until HIV infection of the infant can be confidently excluded. 

• Persons with generalised septic skin disease and skin conditions such as 

eczema, dermatitis and psoriasis. 

• Persons being treated for latent TB infection, as the therapy is likely to 

inactivate the BCG vaccine. 

• Persons who have recently received another parenteral live vaccine (e.g. 

MMR, MMRV, varicella, zoster and yellow fever vaccines), until 4 weeks have 

elapsed, unless these vaccines are given concurrently with the BCG vaccine. 

There are no restrictions on the timing of BCG vaccine in relation to oral live 

vaccines. 

• Persons with significant febrile illness, until 1 month after recovery. 


The normal reaction to BCG vaccination has been described above (see 

4.20.6 Dosage and administration). About 5% of vaccinated persons experience 

adverse events. Injection site abscesses occur in 2.5% of vaccinated persons 

and lymphadenitis in 1%, while up to 1% require medical attention. 39 Gross 

suppurative or generalised complications of BCG vaccination have been treated 

with anti-tuberculosis drugs; however, there is no consensus on the management 

of these complications and specialist advice should be sought from local state/ 

territory tuberculosis services. Anaphylactic reactions have also been reported. 

Keloid formation can occur, but the risk is minimised if the injection is not given 

higher than the level of insertion of the deltoid muscle into the humerus. The 

overall risk of fatal disseminated infection is extremely low (approximately 1 case 

per million vaccinated persons). 13 

4.20.12 Public health management of tuberculosis 

Tuberculosis is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of tuberculosis, 

including management of cases of tuberculosis and their contacts, should 






Although the product information for BCG vaccine specifies that vaccine must 

be used within 8 hours of reconstitution, the National Tuberculosis Advisory 

Committee (NTAC) guidelines recommend that any unused vaccine is discarded 

after a working period of 4 to 6 hours. 

References 




4.20 TUBERCULOSIS

4.21 TYPHOID 


Typhoid fever is a clinical syndrome caused by a systemic infection with 

Salmonella enterica subspecies enterica serovar Typhi (S. Typhi). Paratyphoid fever, 

caused by infection with S. enterica serovar Paratyphi A or B, is similar to, and 

often indistinguishable from, typhoid fever. 1 The two infections are collectively 

known as enteric fever, have largely overlapping geographic distributions, and, 

although there is no vaccine specifically targeted against paratyphoid fever, 

there is evidence to suggest some cross-protection from the oral live attenuated 

typhoid vaccine against Paratyphi B. 2-4 


Typhoid fever has a usual incubation period of 7 to 14 days (range 3 to 60 days). 5 

Although clinical presentations of typhoid fever can be quite variable, a typical 

case presents with a low-grade fever, dull frontal headache, malaise, myalgia, 

anorexia and a dry cough. 5 The fever tends to increase as the disease progresses; 

constipation (more typically diarrhoea in young children), abdominal tenderness, 

relative bradycardia and splenomegaly are common. Complications occur in 10 

to 15% of patients and tend to occur in patients who have been ill for more than 

2 weeks. The more important complications include gastrointestinal bleeding, 

intestinal perforation and typhoid encephalopathy. 5 

Relapse occurs in up to 10% of patients, usually 2 to 3 weeks after the initial fever 

resolves. Chronic asymptomatic biliary carriage of S. Typhi occurs in up to 5% of 

patients with typhoid fever, even after treatment. Chronic carriage is defined by 

the continued shedding of the organism for longer than 1 year. Carriers serve as 

an important reservoir in endemic areas and are of public health significance (e.g. 

if a carrier works in the food industry). 5 


Humans are the sole reservoir of S. Typhi. It is shed in the faeces of those 

who are acutely ill and those who are chronic asymptomatic carriers of 

the organism; transmission usually occurs via the ingestion of faecally 

contaminated food or water. 

The vast majority of typhoid fever cases occur in less developed countries, where 

poor sanitation, poor food hygiene and untreated drinking water all contribute 

to endemic disease, with moderate to high incidence and considerable mortality. 6 

Geographic regions with high incidence (>100 cases per 100 000 population 

per year) include the Indian subcontinent, most Southeast Asian countries 

and several South Pacific nations, including Papua New Guinea. Estimates of 

incidence from African countries are more limited. In many regions, particularly 

the Indian subcontinent, strains partially or completely resistant to many 

antibiotics (including ciprofloxacin) are detected with increasing frequency. 7 


In developed countries, typhoid fever is predominantly a travel-related disease, 

with a considerably greater risk following travel to the Indian subcontinent 

than to other regions. 8,9 Those who travel to endemic regions to visit friends and 

relatives (e.g. immigrants who travel to their former homelands) appear to be 

at considerably greater risk of acquiring typhoid fever than other travellers. 8-10 

There are typically fewer than 150 cases of typhoid fever reported in Australia 

each year, with most following travel to regions with endemic disease. 11 


Monovalent typhoid vaccines 

• Vivotif Oral – CSL Limited/Crucell Switzerland AG (oral live 

attenuated typhoid vaccine). Each enteric-coated capsule contains 

≥2 x 109 viable organisms of attenuated S. Typhi strain Ty21a; gelatin; 

ethylene glycol; sucrose. 3 capsules in a blister pack. 

• Typherix – GlaxoSmithKline (purified Vi capsular polysaccharide 

vaccine). Each 0.5 mL pre-filled syringe contains 25 µg Vi 

polysaccharide of S. Typhi strain Ty2; phenol as preservative; 

phosphate buffer. 

• Typhim Vi – Sanofi Pasteur Pty Ltd (purified Vi capsular 

polysaccharide vaccine). Each 0.5 mL pre-filled syringe contains 25 µg 

Vi polysaccharide of S. Typhi strain Ty2; phenol as preservative; 

phosphate buffer. 

Combination vaccine that contains S. Typhi 

• Vivaxim – Sanofi Pasteur Pty Ltd (formaldehyde-inactivated hepatitis 

A virus [GBM strain] and typhoid Vi capsular polysaccharide). 

Supplied in a dual-chamber syringe which enables the two vaccines 

to be mixed just before administration. Each 1.0 mL dose of mixed 

vaccine contains 160 ELISA units of inactivated hepatitis A virus 

antigens, 25 µg purified typhoid Vi capsular polysaccharide 

strain Ty2; 0.3 mg aluminium as aluminium hydroxide; 2.5 μL 

phenoxyethanol; 12.5 µg formaldehyde; traces of neomycin, bovine 

serum albumin and polysorbate 80. 

The attenuated non-pathogenic S. Typhi strain Ty21a was derived by chemical 

attenuation of a wild-type strain. Attenuated features of Ty21a include the 

absence of the enzyme UDP-galactose-4-epimerase and the Vi capsular 

polysaccharide antigen (an important virulence determinant of S. Typhi). These 

features partially contribute to the non-pathogenicity and, therefore, the safety of 

the oral live vaccine. 12 


4.21 TYPHOID

The oral vaccine Ty21a strain cannot be detected in faeces more than 3 days 

after administration of the vaccine. It stimulates serum IgG, vigorous secretory 

intestinal IgA and cell-mediated immune responses. 12 Clinical trials, with 

different formulations of the vaccine and with a variety of schedules, have 

been undertaken in several countries with endemic typhoid fever (Egypt, 

Chile, Indonesia). These have documented varying degrees of protection 

against the disease. 5,12 

Parenteral Vi polysaccharide vaccines are produced by fermentation of the 

Ty2 strain, followed by inactivation with formaldehyde, and then extraction 

of the polysaccharide from the supernatant using a detergent. 12 The vaccines 

elicit prompt serum IgG anti-Vi responses in 85 to 95% of adults and children 

>2 years of age. The vaccines have also been used in clinical trials in endemic 

regions (Nepal, South Africa, China), indicating moderate protection 

against typhoid fever. 5,12 As with oral typhoid vaccine, herd protection of 

unvaccinated persons living in areas with moderate coverage of parenteral 

vaccine has been demonstrated. 13,14 

Neither the oral nor the parenteral vaccines have been studied in prospective 

clinical trials in travellers to endemic regions. Because many travellers do not 

have any naturally acquired immunity, the protection conferred through typhoid 

vaccination may be less than that documented in the clinical trials mentioned 

above. However, there is circumstantial evidence that the vaccines do provide 

protection to travellers to endemic regions, 8,9 and that 3-yearly revaccination is 

necessary to prolong the protection. 15 




Because the person to be vaccinated will be responsible for looking after 

the course of the oral live attenuated vaccine following purchase, details of 

how it should be transported (from the pharmacy to home) and stored in the 

refrigerator (at home) must be carefully explained. 


Oral live attenuated vaccine 

The vaccine is registered for use in persons ≥6 years of age; it is presented in 

a pack of 3 capsules. Each dose (a whole capsule) is the same for both adults 

and children. 

The vaccination schedule consists of 1 capsule of vaccine on days 1, 3 and 5, 

taken 1 hour before food. The capsule must be swallowed whole with water 

and must not be chewed, since the organisms can be killed by gastric acid. Do 

not give the vaccine concurrently with antibiotics, or other drugs that are active 

against Salmonellae. If possible, antibiotics and other relevant drugs should be 

delayed for 3 days after the last dose of the vaccine (see 4.21.10 Precautions below). 


A 4th capsule taken on day 7 has been shown in one large clinical trial to 

result in a lower incidence of typhoid fever compared with 3 doses. 12,17 

However, giving a 4th dose requires partial use of a second pack. 


Oral typhoid vaccine can be administered at the same time as any of the live 

parenteral vaccines (including yellow fever vaccine or BCG). 12 

The oral live attenuated typhoid vaccine should be separated from the 

administration of inactivated oral cholera vaccine by an interval of at least 

8 hours, and separated from the administration of antibiotics by an interval 

of at least 3 days (see 4.21.10 Precautions below). 

The oral live attenuated typhoid vaccine may be given concurrently with 

mefloquine or with atovaquone/proguanil combination (Malarone) 

(see 4.21.10 Precautions below). 

Parenteral Vi polysaccharide vaccines 

Both monovalent typhoid vaccines (Typherix and Typhim Vi) are registered 

for use in persons ≥2 years of age. The dose of both vaccines is 0.5 mL (for both 

adults and children), to be given by IM injection. 

The dose of the combination typhoid Vi polysaccharide/hepatitis A vaccine 

(Vivaxim) is 1 mL to be given by IM injection. Vivaxim is registered for use in 

persons aged ≥16 years. (See also 4.4 Hepatitis A.) 


Parenteral Vi polysaccharide typhoid vaccines can be given with, or at any 

time before or after, other travel vaccines, such as oral cholera or yellow fever 

vaccines. 


It is recommended that travellers be advised about personal hygiene, food 

safety and drinking boiled or bottled water only. They should be advised that 

raw (or undercooked) shellfish, salads, cold meats, untreated water and ice (in 

drinks) are all potentially ‘high-risk’, as are short (day) trips away from higher 

quality accommodation venues. 


Children aged

Children aged ≥6 years and adults 

Oral typhoid vaccine in either a 3- or 4-dose schedule is recommended for 

children aged ≥6 years and adults who are: 

• travelling to endemic regions, where food hygiene may be suboptimal and 

drinking water may not be adequately treated 

• travelling to endemic regions to visit friends and relatives 

• military personnel 

• laboratory personnel routinely working with S. Typhi. 

The addition of a 4th oral dose, on day 7, is an option as there is evidence that 

4 doses provides greater protection. 12,17 

Revaccination of children aged ≥6 years and adults 

The optimal timing of revaccination against typhoid fever is uncertain and, 

therefore, international recommendations vary considerably. 5,7,9,12 

Where continued exposure to S. Typhi exists (such as occurs with either 

prolonged travel or residence in an endemic region) and the oral live attenuated 

vaccine was used initially, a repeat 3-dose or 4-dose course can be given 3 years 

after a 3-dose course, or 5 years after a 4-dose course. 


For further recommendations on the use of the combination typhoid Vi 

polysaccharide/hepatitis A vaccine see 4.4 Hepatitis A. 

Children aged


The oral live attenuated typhoid vaccine is contraindicated in pregnant women 

(see 4.21.9 Contraindications below). 

The oral live attenuated typhoid vaccine can be given to breastfeeding women. 

Parenteral Vi polysaccharide vaccines are not routinely recommended for 

pregnant or breastfeeding women, but can be given where vaccination is 

considered necessary (see 4.21.7 Recommendations above). 




The only absolute contraindications to typhoid vaccines are: 

• anaphylaxis following a previous dose of any typhoid vaccine 



The oral live attenuated vaccine should not be administered to: 

• children

used, it is recommended that vaccination should be timed so that the last dose of 

vaccine is administered at least 3 days before starting antibiotics or antimalarial 

prophylaxis. 


Typhoid vaccines, both oral and parenteral, are associated with very few adverse 

events and, when adverse events do occur, they tend to be mild and transient. 18 


Abdominal discomfort, diarrhoea, nausea, vomiting and rashes have occasionally 

been reported. 


Local adverse events such as erythema, swelling and pain at the injection site 

occur very commonly in 10 to 20% of vaccine recipients. Systemic adverse events 

are common and include fever (3% of recipients), malaise and nausea. 

4.21.12 Public health management of typhoid fever 

Typhoid fever is a notifiable disease in all states and territories in Australia. 

Further instructions about the public health management of typhoid fever, 

including management of cases of typhoid fever and their contacts, should 





The Australian product information for Vivotif Oral live attenuated vaccine 

does not mention the use of a 4-dose course of the vaccine for either initial or 

repeat vaccination, although this vaccine is registered for use in some other 

countries (e.g. Canada and the United States) in a 4-dose schedule. The ATAGI 

recommends that a 4-dose course can be given to provide increased protection 

against typhoid fever. 

The product information for Vivotif Oral live attenuated vaccine does not include 

pregnancy among the listed contraindications. The ATAGI recommends that 

pregnancy is a contraindication to the oral live attenuated typhoid vaccine. 

The product information for Typhim Vi recommends a booster dose every 2 to 

3 years, and the product information for Vivotif Oral live attenuated vaccine 

recommends a booster every 3 years. The ATAGI also recommends, for those 

at continuing risk, revaccination with a dose of parenteral Vi polysaccharide 

vaccine every 3 years after a previous dose, or revaccination with a 3- or 4-dose 

course of the oral live attenuated vaccine 3 years after a 3-dose course or 5 years 

after a 4-dose course. 

References 




4.22 VARICELLA 


Varicella-zoster virus (VZV) is a DNA virus within the herpes virus family. 1 

Primary infection with VZV causes varicella (chickenpox). Following primary 

infection, VZV establishes latency in the dorsal root ganglia. Reactivation of the 

latent virus manifests as herpes zoster (shingles) 2 (see 4.24 Zoster). 


Varicella is a highly contagious infection spread by respiratory secretions, 

including aerosol transmission, or from the vesicle fluid of the skin lesions of 

varicella or zoster infection. 1 Varicella is usually a mild disease of childhood. 

However, complications occur in approximately 1% of cases. 3 It is more severe 

in adults and in persons of any age who are immunocompromised, in whom 

complications, disseminated disease and fatal illness can occur. 1 

The average incubation period is 14 to 16 days (range 10 to 21 days), but may 

be longer in persons who are immunocompromised, especially after receipt 

of zoster immunoglobulin (ZIG). 2 The period of infectivity is from 48 hours 

before the onset of rash until crusting of all lesions has occurred. 4 A short 

prodromal period of 1 to 2 days may precede the onset of the rash, especially 

in adults. 1,2 In otherwise healthy children, skin lesions usually number between 

200 and 500. 1,2 Acute varicella may be complicated by secondary bacterial skin 

infection, pneumonia, acute cerebellar ataxia (1 in 4000 cases), aseptic meningitis, 

transverse myelitis, encephalitis (1 in 100 000 cases) and thrombocytopenia. In 

rare cases, it involves the viscera and joints. 1 

Congenital varicella syndrome has been reported after varicella infection in 

pregnancy and may result in skin scarring, limb defects, ocular anomalies 

and neurologic malformations. 1,5 There is a higher risk to the fetus if maternal 

infection occurs in the second trimester compared with infection in the first 

trimester (1.4% versus 0.55%). 6 Infants with intrauterine exposure also risk 

developing herpes zoster in infancy (0.8–1.7%), with the greatest risk following 

exposure in the third trimester. 5 Severe neonatal varicella infection can result 

from perinatal maternal varicella. 7 The onset of varicella in pregnant women 

from 5 days before delivery to 2 days after delivery is estimated to result in 

severe varicella in 17 to 30% of their newborn infants. 1,7 

Reactivation of latent VZV as a result of waning cellular immunity results in 

herpes zoster (HZ), a localised vesicular rash. HZ can occur at any age, but 

is more common in older adults and persons who are immunocompromised. 

Complications may include post-herpetic neuralgia and disseminated zoster with 

visceral, central nervous system and pulmonary involvement1 (see 4.24 Zoster). 

There is no specific therapy for uncomplicated varicella infection. Antiviral 

therapy is used in the treatment of complicated or severe varicella, herpes zoster 

disease, and disease in persons who are immunocompromised. 


4.22 VARICELLA


In an unimmunised population in temperate climates, the annual number 

of cases of varicella approximates the birth cohort. 8 Tropical regions have 

a higher proportion of cases in adults. Approximately 5% of cases are 

subclinical. A serosurvey conducted in 1997–1999 found that 83% of the 

Australian population were seropositive by 10–14 years of age. 9 Prior to the 

introduction of a varicella vaccination program in Australia, there were about 

240 000 cases, 1500 hospitalisations and an average of 7 to 8 deaths each year 

from varicella in Australia. 10-12 The highest rates of hospitalisation occur in 

children

as a case of wild-type varicella occurring more than 42 days after vaccination. 

The majority of cases of breakthrough varicella are mild with fewer lesions than 

natural infection. However, breakthrough varicella infections can be contagious, 

particularly if many lesions are present. 28 

Post-marketing studies in the United States have estimated the effectiveness of 

1 dose of VV in children to be 80 to 85% against any disease and 95 to 98% 

against severe varicella. 28-32 Although earlier data suggested persistence of 

immunity in most healthy vaccine recipients, 1 some, but not all, long-term 

follow-up studies have shown that rates of vaccine failure increased over time 

in 1-dose vaccine recipients. For example, in one study, vaccine failure was 

increased 2.6 times in children who received 1 dose of vaccine more than 5 years 

previously, compared with those who had received 1 dose of vaccine within 

5 years. 33 Follow-up from a randomised controlled trial in children 12 months 

to 12 years of age, comparing 1 dose with 2 doses of VV over a 10-year period, 

showed significantly higher protection with 2 doses (98.3% versus 94.4%). 34 

Based on current evidence, 2 doses of a varicella-containing vaccine in children 

from 12 months of age will minimise the risk of breakthrough varicella (see 4.22.7 

Recommendations below). 

Healthy adolescents (≥14 years of age ) and adults require 2 doses of varicella 

vaccine, at least 4 weeks apart, as the response to a single dose of VV decreases 

progressively as age increases and is insufficient to provide adequate protection. 35 

Combination MMRV vaccines have been shown in clinical trials, conducted 

predominantly in children 12 months to 6 years of age, to produce similar rates 

of seroconversion to all four vaccine components compared with MMR and 

monovalent varicella vaccines administered concomitantly at separate injection 

sites. 36-39 In one comparative study assessing seroresponses to a single MMRV 

vaccine dose in 12–14-month-old children, the seroresponse rates to measles, 

mumps and rubella were similar, but varicella seroresponses were lower in 

Priorix-tetra recipients than in ProQuad recipients. 40 However, the clinical 

significance of this is not clear, particularly for MMRV given after MMR vaccine. 

Monovalent varicella vaccines (VV) 

• Varilrix– GlaxoSmithKline (live attenuated Oka strain of varicellazoster 

virus). Lyophilised powder in a monodose vial with separate 

diluent. Each 0.5 mL reconstituted dose contains ≥103.3 plaqueforming 

units (PFU) of attenuated varicella-zoster virus; human 

albumin; lactose; neomycin; polyalcohols. 

• Varivax Refrigerated – CSL Limited/Merck & Co Inc (live attenuated 

Oka/Merck strain of varicella-zoster virus). Lyophilised powder 



4.22 VARICELLA

econstituted dose contains ≥1350 PFU of attenuated varicella-zoster 

virus; sucrose; hydrolysed gelatin; urea; monosodium glutamate; 

residual components of MRC-5 cells; traces of neomycin and bovine 

serum. 







≥103.0 cell culture infectious dose 50% (CCID ) of the Schwarz measles 

50 

virus, ≥104.4 CCID of the RIT 4385 mumps virus, ≥10 50 3.0 CCID of the 

50 

Wistar RA 27/3 rubella virus, and ≥103.3 PFU of Oka varicella-zoster 

virus; lactose; neomycin; sorbitol; mannitol. 






reconstituted dose contains ≥10 3.0 tissue culture infectious dose 50% 

(TCID 50 ) of Enders’ attenuated Edmonston measles virus, ≥10 4.3 

TCID 50 of the Jeryl Lynn B level mumps virus, ≥10 3.0 TCID 50 of the 

Wistar RA 27/3 rubella virus, and ≥10 3.99 PFU of Oka/Merck varicella 

virus; sucrose; hydrolysed gelatin; urea; sorbitol; monosodium 

L-glutamate; human albumin; neomycin; residual components of 

MRC-5 cells; bovine serum albumin. 




Varicella-containing vaccines are less stable than other commonly used live 

viral vaccines, and adherence to storage and reconstitution requirements is very 

important. All vaccines must be reconstituted by adding the entire contents of the 

diluent to the vial containing the pellet, and shaking until the pellet is completely 

dissolved. Available monovalent VVs and MMRV vaccines have different 

requirements following reconstitution. 

Reconstituted Varilrix vaccine should be used as soon as practicable. If storage is 

necessary, hold at ambient temperature for not more than 90 minutes, or at +2°C 

to +8°C for not more than 8 hours. 


Reconstituted Varivax Refrigerated vaccine must be used within 2½ hours. 

Reconstituted Priorix-tetra (MMRV) vaccine should be used as soon as practicable. 

If storage is necessary, hold at +2°C to +8°C for not more than 8 hours. 



The dose of VV and MMRV vaccines is 0.5 mL, to be given by SC injection. 

Priorix-tetra may also be given by IM injection. 42 


The minimum interval between doses of varicella-containing vaccine is 4 weeks. 


VV and MMRV vaccines can be given at the same time as other live attenuated 

parenteral vaccines (e.g. BCG, yellow fever) or other inactivated vaccines 

(including DTPa, hepatitis B, Hib, IPV, MenCCV, hepatitis A and pneumococcal 

conjugate vaccine), 40 using separate syringes and injection sites. If VV or MMRV 

vaccine is not given simultaneously with other live attenuated parenteral 

vaccines, they should be given at least 4 weeks apart. 

If VV is given at the same time as MMR vaccine, they should be given using 

separate syringes and injection sites. MMR vaccine and monovalent VV should 

not be mixed together prior to injection. 

Interchangeability of varicella-containing vaccines 

In general, the two brands of varicella vaccine can be considered interchangeable; 

that is, the 2nd varicella dose does not have to be of the same brand as the 1st. 

The same principle applies to the two available MMRV vaccines, 40 although they 

are not routinely recommended in a 2-dose schedule. 


Children (aged

outbreak. However, note that MMRV vaccine is not recommended for use as the 

1st dose of MMR-containing vaccine in children aged

adequate protection from varicella. 35,43 The 2 doses should be administered 

at least 4 weeks apart. However, a longer interval between vaccine doses is 

acceptable. Lack of immunity to varicella should be based on a negative history 

of previous varicella infection and can be supplemented by serological testing for 

evidence of past infection (see ‘Serological testing for varicella immunity from 

infection and/or vaccination’ below). 

MMRV vaccines are not recommended for use in persons ≥14 years of age, due to 

a lack of data on safety and immunogenicity/efficacy in this age group. If a dose 

of MMRV vaccine is inadvertently given to an older person, this dose does not 

need to be repeated. 

Serological testing for varicella immunity from infection and/or vaccination 

Children who have an uncertain clinical history or no documentation of 

age-appropriate varicella vaccination should be considered susceptible and 

offered vaccination. Although a reliable history of varicella infection correlates 

highly with serological evidence of immunity in young children, 44,45 due to the 

decreasing incidence of varicella in Australia and reduced familiarity with the 

disease, vaccination should be offered, unless confident clinical diagnosis of 

prior natural infection is made. Testing of children to assess serologic status 

prior to vaccination is generally not recommended. Provided there are no 

contraindications, children can safely receive either VV or MMRV vaccine, even if 

prior infection with VZV has occurred (see ‘Children (aged

with VZV. (See also 4.22.12 Public health management of varicella below.) Postexposure 

vaccination is generally successful when given within 3 days, and up 

to 5 days, after exposure, with earlier administration being preferable. 51-55 MMRV 

vaccine can be given to children in this setting, particularly if MMR vaccination is 

also indicated (see 4.22.7 Recommendations above). 


Vaccination of household contacts of persons who are immunocompromised is 

strongly recommended. This is based on evidence that transmission of varicella 

vaccine virus strain is extremely rare and it is likely to cause only mild disease 

(see 4.22.11 Adverse events below). This compares with the relatively high risk 

of severe varicella disease from exposure to wild-type varicella-zoster virus 

in persons who are immunocompromised. 49,56 If vaccinated persons develop 

a rash, they should cover the rash and avoid contact with persons who are 

immunocompromised for the duration of the rash. Zoster immunoglobulin 

(ZIG) need not be given to an immunocompromised contact of a vaccinated 

person with a rash, because the disease associated with this type of transmission 

(should it occur) is expected to be mild (see 4.22.12 Public health management of 

varicella below). 

Healthcare workers, staff working in early childhood education and care, and in 

long-term care facilities 

Refer to 3.3 Groups with special vaccination requirements, Table 3.3.7 Recommended 


diseases for more information. 

Vaccination against varicella is recommended for all non-immune adults, but 

especially for all healthcare workers (HCW), staff working in early childhood 

education and care, and staff working in long-term care facilities. Persons in 

such occupations who have a negative or uncertain history of varicella infection, 

and who do not have documentation of 2 doses of varicella vaccine, should 

be vaccinated with 2 doses of varicella vaccine or have serological evidence of 

immunity to varicella57 (see ‘Adolescents (aged ≥14 years) and adults’ above). 

Testing to check for seroconversion after VV is not recommended (see ‘Serological 

testing for varicella immunity from infection and/or vaccination’ above). 

However, since varicella vaccination is not 100% effective, HCWs and other 

carers should still be advised of the signs and symptoms of infection and how to 

manage them appropriately according to local protocols if they develop varicella. 


Varicella-containing vaccines are contraindicated in pregnant women (see 

4.22.9 Contraindications below). Pregnancy should be avoided for 28 days after 

vaccination. 

Varicella-containing vaccines can be given to breastfeeding women. Most live 

vaccines have not been demonstrated to be secreted in breast milk. Women who 


eceived varicella vaccine while breastfeeding showed no evidence of VZV DNA 

in breast milk samples, and no effects on breastfed infants have been reported. 58 

Post-partum vaccination of women without evidence of varicella immunity need 

not be delayed because of breastfeeding. 






Varicella-containing vaccines are contraindicated in persons who have had: 

• anaphylaxis following a previous dose of any varicella-containing vaccine 



Measles-, mumps-, rubella- and varicella-containing vaccines contain live 


immunocompromised. Thus, both VV and MMRV vaccines are contraindicated 

in the following groups: 

• Persons immunocompromised due to HIV/AIDS. Vaccination with live 

attenuated vaccines can result in a more extensive vaccine-associated rash 

or disseminated infection in persons with AIDS. 59-62 However, varicella 

vaccination (with a 2-dose schedule of VV) of asymptomatic HIV-infected 

persons >12 months of age with an age-specific CD4 + count of ≥15% 

may be considered63-65 (see ‘HIV-infected persons’ in 3.3.3 Vaccination of 

immunocompromised persons). Since studies have not been performed using 

combination MMRV vaccines in asymptomatic HIV-infected persons 

or persons with an age-specific CD4 + count of ≥15%, it is recommended 

that only MMR vaccine and monovalent VV be considered for use in this 

setting. 60,64,65 


immunocompromise (see 3.3.3 Vaccination of immunocompromised persons). 

• Persons receiving high-dose systemic immunosuppressive therapy, such 

as chemotherapy, radiation therapy or oral corticosteroids. Varicellacontaining 






attenuated vaccines after corticosteroid therapy has been discontinued for at 

least 1 month66 (see 3.3.3 Vaccination of immunocompromised persons). 


4.22 VARICELLA

See also 3.3 Groups with special vaccination requirements and 4.9 Measles for more 

information. 


See also 4.22.8 Pregnancy and breastfeeding above. 

Varicella-containing vaccines are contraindicated in pregnant women. 

This is due to the theoretical risk of transmission of the varicella component 

of the vaccine to a susceptible fetus. However, no evidence of vaccine-induced 

congenital varicella syndrome has been reported. Data from a registry, 

established in the United States to monitor the maternal–fetal outcomes of 

pregnant women who were inadvertently administered VV either 3 months 

before, or at any time during, pregnancy, showed that, among the 587 

prospectively enrolled women (including 131 live births to women known to be 

varicella-zoster virus-seronegative), there was no evidence of congenital varicella 

syndrome. 67 The rate of occurrence of congenital anomalies from prospective 

reports in the registry was similar to reported rates in the general United States 

population (3.2%) and the anomalies showed no specific pattern or target organ. 

A non-immune pregnant household contact is not a contraindication to 

vaccination with varicella-containing vaccines of a healthy child or adult in the 

same household. The benefit of reducing the exposure to varicella by vaccinating 

healthy contacts of non-immune pregnant women outweighs any theoretical 

risks of transmission of vaccine virus to these women. 


For additional precautions related to MMRV vaccines, see 4.9 Measles. 


If a varicella-containing vaccine is not given simultaneously with other live 

attenuated parenteral vaccines (e.g. MMR, BCG, yellow fever), the vaccines 

should be given at least 4 weeks apart. 


Administration of MMR or MMRV vaccine should be delayed after 



to measles, mumps, rubella and varicella vaccination may be impaired. 68-70 

VV or MMRV vaccine should not be given for between 3 and 11 months 

following the administration of immunoglobulin-containing products. The 

interval between receipt of the blood product and vaccination depends on the 

amount of immunoglobulin in each product, and is indicated in 3.3 Groups with 

special vaccination requirements, Table 3.3.6 Recommended intervals between either 

immunoglobulins or blood products and MMR, MMRV or varicella vaccination. 69 



immunoglobulin and other blood products and 4.22.13 Variations from product 

information below. 


VV or MMRV vaccines. 

Varicella vaccine may be administered concomitantly with, or at any time in 


immunoglobulin does not interfere with the antibody response to vaccine. 



following vaccination with varicella-containing vaccines, unless the benefits 


administered within this interval, the vaccinated person should be revaccinated 

later at the appropriate time following the product (as indicated in Table 3.3.6 

Recommended intervals between either immunoglobulins or blood products and MMR, 

MMRV or varicella vaccination). 

Rh (D) immunoglobulin (anti-D) may be given at the same time, in different sites 

with separate syringes, or at any time in relation to varicella vaccine, as it does 

not interfere with the antibody response to the vaccine. 


Persons receiving long-term salicylate therapy (aspirin) should be vaccinated if 

indicated, as the benefit is likely to outweigh any possible risk of Reye syndrome 

occurring after vaccination. Natural varicella infection and salicylate use has 

been associated with an increased risk of developing Reye syndrome. However, 

there have been no reports of an association between Reye syndrome and 

varicella vaccination (see 4.22.13 Variations from product information below). 


If using MMRV vaccine, additional adverse events relating to the measles, 

mumps and rubella vaccine components are discussed in 4.9 Measles, 4.11 Mumps 

and 4.18 Rubella. 

Adverse events following administration of varicella-containing vaccines are 

generally mild and well tolerated. 71 

Injection site reactions (pain, redness or swelling) are the most common adverse 

events reported after varicella vaccination, occurring in 7 to 30% of vaccine 

recipients, but are generally well tolerated. 2,71 

A maculopapular or papulovesicular rash may develop after varicella 

vaccination (usually within 5 to 26 days). A VV-associated rash is likely to 

occur in less than 5% of vaccine recipients, and to last for less than 1 week. 72,73 

Rashes typically consist of 2 to 5 lesions and may be generalised (3–5%), or also 

commonly occur at the injection site (3–5%). 66 VV-associated rash may be atypical 

and may not be vesicular. Most varicelliform rashes that occur within the first 


4.22 VARICELLA

2 weeks after vaccination are due to wild-type VZV, with median onset 8 days 

after vaccination (range 1 to 24 days), while vaccine-strain VZV rashes occur at a 

median of 21 days after vaccination (range 5 to 42 days). 74,75 

Transmission of vaccine virus to contacts of vaccinated persons is rare. In the 

United States, where more than 56 million doses of VV were distributed between 

1995 and 2005, there have been only six well-documented cases of transmission 

of the vaccine-type virus from five healthy vaccine recipients who had a vaccineassociated 

rash. 66,76 Contact cases have been mild. 66,76-78 

Fever >39°C has been observed in 15% of healthy children after varicella 

vaccination, but this was comparable to that seen in children receiving placebo. 66 

In adults and adolescents, fever has been reported in 10% of VV recipients. It is 

recommended that parents/carers/vaccine recipients be advised about possible 

symptoms, and given advice for reducing fever, including the use of paracetamol 

for fever in the period 5 to 12 days after vaccination. Higher rates of fever were 

observed in clinical trials of both MMRV vaccines, particularly following dose 1, 

when compared with giving MMR vaccine and monovalent VV at the same 

time but at separate sites. 36-39 Two post-marketing studies in the United States 

identified an approximately 2-fold increased risk of fever and febrile convulsions 

in 1st dose recipients of MMRV vaccine, who were predominantly 12–23 months 

of age, in the period 7 to 10 days79 (or 5 to 12 days) 80 after vaccination, compared 

with recipients of separate MMR and VV vaccines. MMRV vaccination resulted 

in 1 additional febrile seizure for every 2300 doses compared to separate MMR 

and VV vaccination. 79 An increase in fever or febrile convulsions has not been 

identified after the 2nd dose of MMRV vaccine in the United States, although 

most 2nd dose recipients were aged 4–6 years, an age at which the incidence of 

febrile convulsions is low. 81 These post-marketing studies were in children who 

received ProQuad; however, it is anticipated that this side effect profile would be 

similar in Priorix-tetra recipients. 

A post-marketing study in the United States reported serious adverse events 

temporally, but not necessarily causally, linked to varicella vaccination, such 

as encephalitis, ataxia, thrombocytopenia and anaphylaxis, were very rare and 

occurred in

eported in a 9-year follow-up of 7000 varicella vaccinated children. 27 (See also 

4.24 Zoster.) 

4.22.12 Public health management of varicella 

Varicella is a notifiable disease in most states and territories in Australia. 

Further instructions about the public health management of varicella, including 

management of cases of varicella and their contacts, should be obtained from 

state/territory public health authorities (see Appendix 1 Contact details for 

Australian, state and territory government health authorities and communicable 


• Zoster Immunoglobulin-VF (human) – CSL Limited. 160 mg/ 

mL immunoglobulin (mainly IgG) prepared from human plasma 

containing high levels of antibody to the varicella-zoster virus. Single 

vials contain 200 IU of varicella-zoster antibody, with the actual 

volume stated on the label on the vial. Also contains glycine. 

High-titre zoster immunoglobulin (ZIG) is available from the Australian Red 

Cross Blood Service on a restricted basis for the prevention of varicella in highrisk 

subjects who report a significant exposure to varicella or HZ. ZIG has no 

proven use in the treatment of established varicella or zoster infection. ZIG is 

highly efficacious, but is often in short supply. Normal human immunoglobulin 

(NHIG) can be used for the prevention of varicella if ZIG is unavailable. 

Post-exposure prophylaxis using varicella vaccine may also be indicated, if 

vaccination is not contraindicated (see below). 

Zoster immunoglobulin should only be given by IM injection. 

‘Significant exposure’ to VZV is defined as living in the same household as a 

person with active varicella or HZ, or direct face-to-face contact with a person 

with varicella or HZ for at least 5 minutes, or being in the same room for at least 

1 hour. In the case of varicella infection, the period of infectivity is from 48 hours 

before the onset of rash until crusting of all lesions has occurred. Transmission 

from a person with localised zoster is less likely than from a person with 

varicella. 4 

Immunocompetent varicella contacts should be tested for varicella-zoster 

antibodies. 

ZIG must be given early in the incubation period (within 96 hours of exposure), 

but may have some efficacy if administered out to as late as 10 days post 

exposure. ZIG is able to prevent or ameliorate varicella in infants

should be tested for varicella-zoster antibodies following contact with a person 

with confirmed varicella. However, testing should not delay ZIG administration 

after initial exposure to a case. 84-86 

ZIG administration (preferably within 96 hours and up to 10 days after exposure) 

is required for the following groups and should not be delayed by testing (if 

indicated below): 

• Pregnant women who are presumed to be susceptible to varicella infection. 

If practicable, they should be tested for varicella-zoster antibodies before 

ZIG is given. 5 

• Neonates whose mothers develop varicella from 7 or fewer days before 

delivery to 2 days after delivery. ZIG must be given, as the neonatal mortality 

without ZIG is up to 30% in this setting. 1,7 ZIG must be given as early as 

possible in the incubation period. 

• Neonates exposed to varicella in the 1st month of life, if the mother has no 

personal history of infection with VZV and is seronegative. 27 ZIG should 

be given, due to the increased risk of severe varicella in newborns of 

seronegative women. 

• Premature infants (born at

high-dose intravenous NHIG are likely to be protected and probably do not 

require ZIG if the last dose of NHIG was given 3 weeks or less before exposure. 

Vaccination for post-exposure prophylaxis 

If VV is not contraindicated, it can be offered to non-immune age-eligible 

children and adults who have a significant exposure to varicella or HZ and 

wish to be protected against primary infection with VZV (see ‘Post-exposure 

vaccination’ in 4.22.7 Recommendations above). 51-55 Vaccination has the added 

benefit of reducing the likelihood of varicella infection, particularly moderate 

to severe disease, following exposure, and also provides long-term protection. 

Vaccination of exposed persons during outbreaks has also been shown to prevent 

further cases and to control outbreaks. 55 If MMR vaccination is also indicated, 

MMRV vaccine can be used in children

MMRV vaccine should not be used routinely as the 1st dose of MMR-containing 

vaccine in children aged

4.23 YELLOW FEVER 


Yellow fever is a viral haemorrhagic fever caused by an RNA flavivirus that 

is transmitted by mosquitoes. Aedes aegypti, a highly domesticated mosquito 

found throughout the tropics, is the vector responsible for person-to-person 

transmission of the yellow fever virus in urban and inhabited rural areas in 

endemic countries. 


The clinical spectrum of yellow fever varies from a non-specific febrile illness to 

fatal haemorrhagic fever. 1 After an incubation period of 3 to 6 days, the disease 

begins abruptly with fever, prostration, myalgia and headache. The patient 

appears acutely ill with congestion of the conjunctivae; there is an intense 

viraemia during this ‘period of infection’, which lasts 3 to 4 days. 1 This may be 

followed by the ‘period of remission’, in which the fever and symptoms settle 

over 24 to 48 hours, during which the virus is cleared by immune responses. 1 

Approximately 15 to 25% of patients may then relapse with a high fever, 

vomiting, epigastric pain, jaundice, renal failure and haemorrhage: ‘the period 

of intoxication’. 1 These complications can be severe, and reflect the viscerotropic 

nature of the yellow fever virus (its ability to infect the liver, heart and 

kidneys). The case-fatality rate varies widely, but can be more than 20% in local 

populations. 2 


Yellow fever occurs in tropical regions of Africa and Central and South America. 

In both regions the virus is enzootic in rainforest monkeys and canopy mosquito 

species; sporadic human cases occur when people venture into these forests 

(‘sylvatic or jungle yellow fever’). 1 

In moist savannah regions in Africa, especially those adjacent to rainforests, tree 

hole-breeding Aedes mosquito species are able to transfer yellow fever virus from 

monkeys to people and then between people, leading to small-scale outbreaks 

(‘intermediate yellow fever’). 

Ae. aegypti occurs in both heavily urbanised areas and settled rural areas in 

tropical Africa and the Americas. 1 Epidemics of ‘urban yellow fever’ occur when 

a viraemic individual (with yellow fever) infects local populations of Ae. aegypti; 

such epidemics can be large and very difficult to control. Although Ae. aegypti 

also occurs throughout much of tropical Asia and Oceania (including north 

Queensland), yellow fever has never been reported from these regions. 

Although yellow fever is undoubtedly markedly under-reported, it is clear that 

there has been a considerable increase in the reported number of outbreaks, and 

therefore cases, of yellow fever in past decades. 3 Most of this increase was in 


4.23 YELLOW FEVER

Africa, particularly in West African countries. 3,4 In 2008, there were 24 cases of 

yellow fever reported near Asunción in Paraguay with 8 deaths. 5 

The risk of susceptible travellers acquiring yellow fever varies considerably 

with season, location, duration of travel and utilisation of mosquito avoidance 

measures. There have been reported cases of yellow fever, all fatal, in 

unvaccinated travellers to Africa and South America. 6 


• Stamaril – Sanofi Pasteur Pty Ltd (live attenuated yellow fever virus 

[17D strain]). Lyophilised powder in a monodose vial with a pre-filled 

diluent syringe. Each 0.5 mL reconstituted dose contains ≥1000 mouse 

LD 50 units; 16.0 mg lactose; 8.0 mg sorbitol; 0.833 mg L-histidine 

hydrochloride. May contain traces of egg proteins. 

Yellow fever vaccine is a live, freeze-dried preparation of attenuated 17D strain 

yellow fever virus cultured in, and harvested from, embryonated chicken eggs. 

The vaccine does not contain antibiotics, preservatives or gelatin. 

Vaccination elicits protective levels of neutralising antibodies in approximately 

90% of adult vaccine recipients by day 14, and in virtually all by day 28. 7 

Immunity is long-lasting and perhaps life-long; regardless, revaccination is 

required after 10 years under International Health Regulations for a valid 

International Certificate of Vaccination or Prophylaxis (ICVP) against yellow 

fever. Because the vaccine produces a transient very low level viraemia in healthy 

adult recipients, they cannot serve as a source of infection for mosquitoes. 7 

Although the efficacy of the yellow fever vaccine has never been determined in 

prospective clinical trials, there is considerable observational evidence that it is 

very effective in preventing the disease. 7 




Stamaril must be reconstituted by adding the entire contents of the diluent syringe 

to the vial and shaking until the powder is completely dissolved. Reconstituted 

vaccine must be used within 1 hour. 


The dose of yellow fever vaccine for children and adults is 0.5 mL, to be given by 

either IM or SC injection. 

Test doses of yellow fever vaccine should never be used (see 4.23.13 Variations 

from product information below). 



If administration of both yellow fever and other parenteral live viral vaccines is 

indicated, the vaccines should be given either on the same day or at least 4 weeks 

apart (see 4.23.10 Precautions below). 

Inactivated vaccines and oral live vaccines relevant to travel (e.g. cholera, 

typhoid) can be given with, or at any time before or after, yellow fever vaccine. 

Yellow fever vaccine can be given at the same time as the Imojev Japanese 

encephalitis vaccine, 9 using separate syringes and separate injection sites. 


Children aged

are free to set their own requirements for entry and some countries require a 

valid International Certificate of Vaccination or Prophylaxis against yellow 

fever or a valid letter of exemption for all arriving travellers. A country may 

require such documentation even for travellers who are only in transit through 

that country. The most recent WHO list of individual country yellow fever 

vaccination requirements and recommendations for travellers can be found at 

www.who.int/ith/chapters/ith2012en_countrylist.pdf. As yellow fever disease 

patterns, like other diseases, are constantly changing, it is recommended that 

the entry requirements for yellow fever vaccination for the countries a traveller 

intends to enter or transit through be confirmed by contacting the country’s 

foreign missions in Australia. 

Travellers >1 year of age entering or returning to Australia within 6 days of 

leaving a country on Australia’s list of yellow fever declared places are required 

to have a valid International Certificate of Vaccination or Prophylaxis with 

proof of valid yellow fever vaccination (see below). This list is developed based 

on the WHO list of countries with risk of yellow fever virus transmission and 

international surveillance data, and is available from the Australian Government 

Department of Health and Ageing’s yellow fever fact sheet (www.health.gov.au/ 

yellowfever). Travellers who do not have a valid certificate are provided with 

information on yellow fever and required to promptly seek medical assessment if 

they develop relevant symptoms within 6 days of leaving the declared place. 

Yellow fever vaccine can be administered only by Yellow Fever Vaccination 

Centres approved by the relevant state or territory health authorities. Each 

yellow fever vaccination is to be recorded in an International Certificate of 

Vaccination or Prophylaxis, with proof of valid yellow fever vaccine; the 

certificate must include the vaccinated person’s name and signature (or the 

signature of a parent or guardian of a child), and the signature of a person 

approved by the relevant health authority. The date of the vaccination must be 

recorded in day–month–year sequence, with the month written in letters, and the 

official stamp provided by the state or territory health authority must be used. 

The certificate becomes valid 10 days after vaccination, and remains valid for 

10 years. 

Note: People with a true contraindication to yellow fever vaccine (see 4.23.9 

Contraindications below) who intend to travel to yellow fever risk countries 

should obtain a letter from a doctor, clearly stating the reason for withholding 

the vaccine. The letter should be formal, signed and dated, and on the practice’s 

letterhead. Arriving travellers who possess an exemption from the yellow fever 

vaccination are provided with information on yellow fever and required to 

promptly seek medical assessment if they develop relevant symptoms. 



Yellow fever vaccine is not recommended for pregnant women or women 

breastfeeding infants aged

Altered immune status 

As with all live viral vaccines, the yellow fever vaccine should generally not 

be given to people who are immunocompromised due to either disease or 

medical treatment (see 3.3.3 Vaccination of immunocompromised persons). However, 

studies of small numbers of HIV-infected participants, mainly travellers with 

CD4 + counts >200 per μL, have shown reduced immune response, but good 

tolerability. 15 

Thymus disorders 

People with a history of any thymus disorder, including myasthenia gravis, 

thymoma, thymectomy and DiGeorge syndrome, or thymic damage from 

chemoradiotherapy or graft-versus-host disease, should not be given the yellow 

fever vaccine due to the increased risk of yellow fever vaccine-associated 

viscerotropic disease (see 4.23.11 Adverse events below). 



The risk of severe adverse events following yellow fever vaccine is considerably 

greater in those aged ≥60 years than in younger adults. 16-19 

Adults ≥60 years of age should be given yellow fever vaccine only if they intend 

to travel to endemic countries (as recommended above) and they have been 

informed about the (albeit very low) risks of developing a severe complication. 


The administration of other parenteral live viral vaccines (e.g. MMR, MMRV, 

varicella or zoster vaccine) should be on the same day as yellow fever vaccine, or 

separated by a 4-week interval. 


Mild adverse events 

Adverse events following yellow fever vaccine are generally mild. Vaccine 

recipients often report mild headaches, myalgia and low-grade fevers or other 

minor symptoms for 5 to 10 days post vaccination. In clinical trials in which 

symptoms are actively elicited, up to 25% of vaccine recipients report mild 

adverse events and up to 1% curtail regular activities. 7,19,20 

Immediate hypersensitivity reactions 

Immediate hypersensitivity reactions, including anaphylaxis, following yellow 

fever vaccine are very rare, with an incidence of less than 1 in 1 million, and 

occur principally in people with anaphylactic sensitivity to eggs. 7,18,19 Although 

it has been suggested that an anaphylactic sensitivity to gelatin (added as a 

stabiliser to some yellow fever vaccines) may also precipitate anaphylaxis 

following vaccination, 21 Stamaril does not contain gelatin. 


Vaccine-associated neurotropic adverse events 

Yellow fever vaccine-associated neurotropic disease (YF-AND) is rare. 18 

At least 25 cases of meningoencephalitis following yellow fever 

vaccination have been reported. 7 However, 15 of these cases occurred in 

the 1950s in infants ≤7 months of age. Following recommendations in 

the early 1960s not to vaccinate young infants, the incidence of vaccineassociated 

meningoencephalitis declined considerably. 7 Nevertheless, 

these adverse events, albeit very rare, still occur in adults; the risk is 

greater in persons ≥60 years of age. 16,17 

Vaccine-associated viscerotropic adverse events 

Recently, an apparently very rare (and often fatal) complication, yellow fever 

vaccine-associated viscerotropic disease (YF-AVD), characterised by multiorgan 

system failure, has been recognised following yellow fever vaccination. It 

appears that overwhelming infection with the 17D vaccine virus is responsible 

for these viscerotropic adverse events. 7,18 

Vaccine-associated viscerotropic adverse events do not appear to be caused by 

altered virulence of the vaccine virus, but rather appear to be related to host 

factors. Although cases have occurred in younger persons, it is apparent that the 

risk is increased with advanced age, particularly in those aged ≥60 years. 16,17,19 

Another host factor associated with an increased risk of a viscerotropic adverse 

event is pre-existing thymus disease. Published reports of YF-AVD cases have 

indicated that 4 of the 27 reported cases had a history of thymic tumour and 

thymectomy, both uncommon conditions. 18,22 

4.23.12 Public health management of yellow fever 

Yellow fever is a notifiable and quarantinable disease in all states and territories 

in Australia. 

Further instructions about the public health management of yellow fever, 

including management of cases of yellow fever and their contacts, should 





The product information states that pregnancy is a contraindication to the yellow 

fever vaccine. The ATAGI recommends instead that pregnant women who insist 

on travelling to endemic countries should be vaccinated. 

The product information suggests that a 0.1 mL test dose of yellow fever vaccine 

can be used intradermally to assess an individual with suspected allergy to the 

vaccine. The ATAGI instead recommends that (with the exception of Q fever 

vaccine) test doses should never be used. 

References 




4.23 YELLOW FEVER

4.24 ZOSTER (herpes zoster) 


Varicella-zoster virus (VZV) is a DNA virus that is a member of the herpesvirus 

family. Primary infection with VZV is known as varicella or ‘chickenpox’. 1 

Herpes zoster (HZ), or ‘shingles’, is caused by reactivation of latent VZV, which 

typically resides in the dorsal root or trigeminal nerve ganglia following primary 

infection. 1 


Reactivation of VZV causing HZ is thought to be particularly due to a decline in 

cellular immunity to the virus, and presents clinically as a unilateral vesicular 

rash in a dermatomal distribution in the majority of cases. A prodromal phase 

occurs 48 to 72 hours prior to the appearance of the lesions in 80% of cases. 2 

Associated symptoms may include headache, photophobia, malaise, and an 

itching, tingling or severe pain in the affected dermatome. 3,4 In the majority of 

patients, HZ is an acute and self-limiting disease, with the rash lasting 10 to 

15 days. 1,3 However, complications can occur, especially with increasing age. 

Post-herpetic neuralgia (PHN), the most frequent debilitating complication 

of HZ, is a neuropathic pain syndrome that persists or develops after 

the dermatomal rash has healed. By definition, PHN is established when 

pain persists for longer than 3 months after the onset of the rash. 5,6 Other 

complications may occur, depending on the site of reactivation. These include 

ophthalmic disease (such as keratitis and chorioretinitis), neurological 

complications (such as meningoencephalitis and myelitis), secondary bacterial 

skin infection, scarring and pneumonia. 7 Rarely, disseminated HZ may develop, 

with widespread vesicular rash, and visceral, central nervous system and 

pulmonary involvement. Disseminated disease is more common in persons who 

are immunocompromised. 4 Dermatomal pain without the appearance of rash is 

also documented (zoster siné herpéte). 

Antiviral therapy, if initiated within 3 days of the onset of HZ, has been shown 

to reduce the severity and duration of HZ and may reduce the risk of developing 

PHN. 8-12 However, despite medical therapy, PHN may persist for years and can 

be refractory to treatment. 13 


HZ occurs most commonly with increasing age (>50 years), immunocompromise, 

and following a history of varicella in the 1st year of life. The lifetime risk of 

reactivation of VZV causing HZ is estimated to be approximately 20 to 30% 

and it affects half of those who live to 85 years. 1,14-16 Second attacks of HZ occur 

in approximately 5% of immunocompetent persons, but are more frequent 

in persons who are immunocompromised. 3,17,18 Using Australian general 

practice and other data, approximately 490 cases per 100 000 (range 330–830 

per 100 000) are estimated to occur annually in all ages, with approximately 


1000 cases per 100 000 population in persons aged ≥50 years. 19-22 In the large 

efficacy study of zoster vaccine in the United States, the incidence of HZ in 

unimmunised participants ≥60 years of age was 1112 cases per 100 000 personyears. 

23 The incidence in persons aged 50–59 years is lower, with one study 

estimating a rate of 470 per 100 000 person-years. 24 The risk of HZ increases 

with immunocompromise; for example, rates of HZ are up to 15 times higher in 

those who are immunocompromised due to HIV infection, and, in the 1st year 

following haematopoietic stem cell transplantation (HSCT), up to 30% of patients 

may develop HZ. 3,25 

Overall, an estimated 13 to 26% of patients with HZ develop complications. 

Complications occur more frequently with increasing age, and with 

immunocompromise. 26,27 PHN occurs infrequently in young people, but, in 

patients over the age of 50 years, it complicates HZ in 25 to 50% of cases. 26,27 

Modelling studies of the impact of universal childhood vaccination programs 

for varicella have predicted that a rise in the incidence of HZ could occur, based 

on the assumption that exposure to wild-type VZV circulating in the community 

boosts immunity. 28 However, to date, multiple studies and surveillance data do 

not demonstrate any consistent changes in overall HZ incidence in the United 

States, which has a universal varicella vaccination program that commenced 

in 1995. 29-31 Australian data show an increase in HZ GP consultation rates 

over time, commencing prior to varicella vaccine introduction, which is 

likely to be due to the increasing age of the population. Age-standardised HZ 

hospitalisation rates have not declined since introduction of varicella vaccine, 

and the use of zoster vaccine has not yet been extensive enough in any country 

to expect an impact on HZ epidemiology. 32-34 In the United States, the incidence 

of HZ in children 50 years of age. It is important to note 

that the registered varicella vaccines are not indicated for use in preventing 

HZ in older people and Zostavax is not indicated for use in younger people 

who have not been previously immunised or infected with VZV. Zostavax is 

not indicated for use for therapeutic benefit during an acute HZ episode, nor 

for the treatment of PHN. 

A single large, randomised, double-blind, placebo-controlled efficacy study of 

the frozen formulation of Zostavax (known as the ‘Shingles Prevention Study’ 


4.24 ZOSTER (HERPES ZOSTER)

[SPS]) was conducted among 38 546 adults aged ≥60 years and demonstrated 

that Zostavax significantly reduced the likelihood of developing both HZ and 

PHN. 23 Vaccination reduced the incidence of HZ by 51.3%, the incidence of PHN 

by 66.5%, and the burden of illness associated with HZ by 61.1% over a median 

of more than 3 years follow-up. 23 The vaccine was more efficacious in reducing 

HZ in persons aged 60–69 years than in those aged 70–79 years (64% compared 

with 41% efficacy). However, efficacy against PHN was similar in both age 

groups. 23 Efficacy against HZ in the ≥80 years age group was lower (18% and not 

statistically different to placebo). However, there were fewer participants of this 

age in the SPS. 36 In those who developed HZ despite vaccination, the severity 

of pain associated with the episode was also reduced. 37 Another randomised 

controlled study in >22 000 50–59-year olds demonstrated a reduction in the 

incidence of HZ after a follow-up period of 1 year or more, with a vaccine 

efficacy for preventing HZ of 69.8%. 38 In these clinical trials many participants 

were treated with antiviral and pain medication for their HZ, suggesting that 

the effect of the vaccine was in addition to any benefit obtained from medical 

therapy. 23,38 Efficacy of a single dose of zoster vaccine appears to decline over 

time, with recent data suggesting persistent efficacy through to the 5th year post 

vaccination, with uncertain efficacy beyond that point. 39 The need for a booster 

dose has not yet been determined. 

The Shingles Prevention Study, together with other smaller studies, 

demonstrated that Zostavax is safe and generally well tolerated among adults 

≥50 years of age. 23,38 In the SPS, the most common adverse events were injection 

site reactions, with Zostavax more likely to result in erythema, pain and swelling 

at the injection site than placebo (48% versus 17%, respectively). Varicellalike 

rashes at the injection site were also more common in vaccine recipients; 

however, varicella-like rash not localised to the injection site did not occur more 

often. Varicella- or zoster-like rashes that were PCR-positive for VZV were 

mostly due to wild-type VZV. 23 Fever was no more common in vaccine recipients; 

however, the rate of vaccine-related systemic symptoms was higher (Zostavax 

6.3% versus placebo 4.9%), with the most frequently reported systemic symptoms 

being headache and fatigue. 23 Mild to moderate adverse events, particularly 

injection site reactions, were higher in vaccine recipients aged 50–59 years than in 

those aged ≥60 years. 38,40 

In Australia, a refrigerated form of Zostavax is registered on the basis of 

comparable immunogenicity and safety to the frozen vaccine formulation that 

was used in the SPS. 41 Zostavax was registered for use in persons 50–59 years 

of age based on a study that demonstrated similar immunogenicity in this age 

group compared with those ≥60 years of age, 40 and has since been shown to 

reduce the incidence of HZ in this population. 38 A study of the simultaneous 

administration of Zostavax with inactivated influenza vaccine (given separately 

and at different injection sites) demonstrated comparable immunogenicity and 

safety to giving the vaccines at different times. 42 A study of the simultaneous 


administration of Zostavax with 23-valent pneumococcal polysaccharide vaccine 

(Pneumovax 23; 23vPPV) suggested that the immunogenicity of Zostavax was 

reduced when administered simultaneously with Pneumovax 23, compared with 

administration 4 weeks apart. 43 The immunogenicity of Pneumovax 23 was not 

affected. However, an observational study from the United States suggests this 

may not impact on Zostavax effectiveness. 44-46 

Zostavax availability in Australia has been limited due to manufacturer supply 

constraints. 

• Zostavax – CSL Limited/Merck & Co Inc (live attenuated Oka/Merck 

strain of varicella-zoster virus). Lyophilised powder in a monodose 

vial with separate diluent. Each 0.65 mL reconstituted dose contains 

≥19 400 plaque-forming units of attenuated varicella-zoster virus; 

sucrose; gelatin; urea; monosodium glutamate; residual components 

of MRC-5 cells; traces of neomycin and bovine serum albumin. 




Zostavax is less stable than other commonly used live viral vaccines, and 

adherence to storage and reconstitution requirements is very important. 

Zostavax must be reconstituted by adding the entire contents of the diluent 


Reconstitute immediately upon removal from the refrigerator. Reconstituted 

vaccine must be used within 30 minutes. 


The dose of Zostavax is 0.65 mL, to be given by SC injection. 

Zostavax must never be given where varicella (chickenpox) vaccine is indicated. 

Zoster vaccine is only registered for use in adults ≥50 years of age. 


Zostavax can be given at the same time as influenza vaccine, 42 using separate 

syringes and injection sites. 

Simultaneous administration of Zostavax with pneumococcal polysaccharide 

vaccine is not routinely recommended; if possible the two vaccines should be 

given at least 4 weeks apart. However, inadvertent administration of Zostavax 

and pneumococcal polysaccharide vaccine at the same time or at an interval of 

less than 4 weeks does not require revaccination (see 4.24.4 Vaccine above). 



Zostavax can be administered at the same visit as, or at any time following 

receipt of, other inactivated vaccines (e.g. tetanus-containing vaccines), if 

required. 

If administration of both Zostavax and another live parenteral vaccine (e.g. MMR 

or yellow fever) is indicated, the vaccines should be given either on the same day 

or at least 4 weeks apart. (See also 4.22 Varicella.) 



A single dose of zoster vaccine is recommended for adults ≥60 years of age who 

have not previously received a dose of zoster vaccine. Routine serological testing 

prior to receipt of zoster vaccine is not indicated and it is not necessary to elicit 

a history of previous varicella (chickenpox) infection (see ‘Serological testing 

before and after zoster vaccination’ below). 

Persons with chronic medical conditions, such as arthritis, chronic renal 

failure, diabetes and other conditions, can be given zoster vaccine, unless a 

contraindication or precaution exists due to their condition or medical treatment 

(see 4.24.9 Contraindications and 4.24.10 Precautions below). Persons with 

significant immunocompromise should not receive zoster vaccine (see also 3.3.3 

Vaccination of immunocompromised persons). 

The zoster vaccine has been shown to be less efficacious in persons aged ≥80 

years and may be less likely to provide a clinical benefit in this age group (see 

4.24.4 Vaccine above). 

Adults aged 50–59 years 

Routine population-based use of zoster vaccine in persons aged 50–59 years is 

not recommended. Although the incidence of HZ in persons 50–59 years of age 

is higher than in younger age groups, 19,22 and zoster vaccine is efficacious in 

50–59-year olds, 38 the likelihood of developing PHN and other complications 

of HZ is lower in this age group than in those ≥60 years of age. 24,48 Persons aged 

50–59 years who wish to protect themselves against HZ can be vaccinated; 

however, the duration of efficacy, and need for a booster dose at a later age, is 

not yet determined (see 4.24.4 Vaccine above). 

Persons aged

diagnosis. In addition, the risk of a repeat episode of zoster has been estimated 

at approximately 5% in immunocompetent persons. 17,18,48 Persons with a history 

of HZ were excluded from the SPS, so no data on the efficacy of the vaccine in 

those with a history of HZ is available. The safety and immunogenicity of zoster 

vaccine in persons with a history of HZ has been studied in one small clinical 

trial; the vaccine was well tolerated and immunogenic. 49 Injection site reactions 

were more common in vaccine recipients than in placebo recipients, but similar 

to vaccine recipients in the SPS. Systemic adverse events were similar between 

groups. 23 The length of time following an episode of HZ after which it would be 

reasonable to vaccinate has not been established. However, it is suggested that 

the vaccine could be given at least 1 year after the episode of HZ. 

Persons previously vaccinated with varicella vaccine 

Zoster vaccination of persons who have previously received varicella vaccine is 

not recommended at this time. There have been limited studies of the safety and 

immunogenicity of zoster vaccine in this setting, and the currently available data 

are insufficient to suggest a benefit from vaccination. It is not yet known whether, 

in the future, populations vaccinated with varicella vaccine will experience rates 

of HZ sufficient to warrant zoster vaccination. Preliminary information suggests 

that the incidence of HZ in persons who have received varicella vaccine is lower 

than in those infected with wild-type varicella. 30 

Persons with immunocompromise due to HIV/AIDS 

Studies of the use of zoster vaccine in HIV-infected persons have not been 

completed. However, persons with asymptomatic HIV infection may be 

considered for vaccination on a case-by-case basis after seeking appropriate 

specialist advice. Serological confirmation of previous VZV infection must be 

obtained prior to vaccination (see ‘Serological testing before and after zoster 

vaccination’ below). Although asymptomatic HIV-infected persons are likely 

to have a higher relative risk of developing HZ in the future, 25 it is possible that 

both the efficacy and the safety of zoster vaccination may be reduced in such 

recipients, as compared with uninfected persons. 

Vaccination with zoster vaccine is not recommended for persons with AIDS or 

symptomatic HIV infection (see 3.3 Groups with special vaccination requirements, 

Table 3.3.4 Categories of immunocompromise in HIV-infected persons, based on 

age-specific CD4 + counts and percentage of total lymphocytes), or significant 

immunocompromise due to other diseases and/or treatment (see 4.24.9 

Contraindications below). 

Persons anticipating future significant immunocompromise 

Immunocompetent persons who anticipate alteration of their immunity because 

of their existing illness can be given zoster vaccine on a case-by-case basis 

after seeking appropriate specialist advice. 36 Persons with conditions such as 

chronic lymphocytic leukaemia, conditions requiring organ transplantation, 50 



solid tumours that will require future chemotherapy or radiation therapy, and 

inflammatory diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, 

inflammatory bowel disease, psoriasis) may have minimal alteration to their 

immune system, but can anticipate significant immunocompromise in the future 

due to their disease and/or treatment. Since these persons are at higher risk of 

developing zoster than if they remained immunocompetent, vaccination at least 

1 month prior to the onset of immunocompromise may be appropriate (after 

seeking specialist advice). 36 Serological confirmation of previous VZV infection 

must be obtained prior to vaccination (see ‘Serological testing before and after 

zoster vaccination’ below). 


Vaccination is recommended for persons ≥50 years of age who are household 

contacts of a person who is immunocompromised. Based on evidence that the 

rate of VZV-like rashes after vaccination is extremely low, it is unlikely that 

transmission of vaccine-associated virus to a susceptible contact would occur. 23 

If a vaccinated person develops a varicella- or zoster-like rash, they should cover 

the rash and avoid contact with persons who are immunocompromised for the 

duration of the rash. The efficacy of the HZ vaccine is less than 100%, and rashes 

in vaccinated persons may be due to reactivation of wild-type VZV. If household 

contacts (

Laboratory testing to check for an immune response after zoster vaccination 

is not recommended. Zoster vaccine boosts both humoral (IgG) and cellular 

immune responses; however, confirmation of such immune responses is neither 

necessary nor predictive of protection against the development of zoster. 


VZV-containing vaccines are contraindicated in pregnant women, although 

women of child-bearing age are not eligible for zoster vaccination. Pregnancy 

should be avoided for 28 days after vaccination (see 4.22 Varicella). 

A non-immune pregnant household contact is not a contraindication to zoster 

vaccination. 





Zoster vaccine is contraindicated in persons who have had: 

• anaphylaxis following a previous dose of any VZV-containing vaccine 



Live attenuated zoster vaccine is contraindicated in persons with significant 

immunocompromise due to either a primary or acquired medical condition, or 

due to medical treatment. This includes persons receiving high-dose systemic 

immunosuppressive therapy, such as chemotherapy, radiation therapy or 

oral corticosteroids; persons suffering from malignant conditions of the 

reticuloendothelial system (such as lymphoma, leukaemia, Hodgkin’s disease); 

and any person with similar immunocompromise due to a disease or treatment 

(see 3.3.3 Vaccination of immunocompromised persons). 

Persons who have been receiving high-dose systemic steroids (or equivalent) 

and have ceased therapy may be vaccinated (see 3.3.3 Vaccination of 

immunocompromised persons). Persons on low-dose corticosteroids or less 

significantly immunocompromised than described above, may be considered for 

vaccination on a case-by-case basis. Studies of zoster vaccine in such persons are 

being conducted. 



If zoster vaccine is to be given around the same time as another live viral 

parenteral vaccine (e.g. MMR, yellow fever), the vaccines should be given either 

at the same visit or at least 4 weeks apart. 



Vaccination before or after immunoglobulin or blood product administration 

Zoster vaccine can be given at any time before or after administration of 

immunoglobulin or any antibody-containing blood product. This is because 

zoster vaccine is indicated in persons who, because of their age, are assumed to 

have had a previous VZV infection and, therefore, already have serum antibody 

levels comparable to those found in blood products. (See also 3.3.4 Vaccination of 

recent recipients of normal human immunoglobulin and other blood products.) 


Persons receiving long-term salicylate therapy (aspirin) can be vaccinated if 

indicated. There have been no reports of an association between Reye syndrome 

and varicella vaccination, and it is unlikely that vaccination of a previously VZVinfected 

older person with zoster vaccine carries any risk of Reye syndrome. 

Persons receiving antiviral medication 

It is possible that the use of antivirals with anti-VZV activity, such as acyclovir, 

famciclovir or valaciclovir, may interfere with the replication of the Zostavax 

live attenuated virus. Persons on such antiviral medication should cease 

treatment no less than 24 hours prior to vaccination and for at least 14 days after 

vaccination. 36,53 


Injection site reactions (including erythema, pain, swelling and/or itch at the 

injection site) occurred in approximately half of clinical trial participants given 

Zostavax, irrespective of a previous history of HZ (see also 4.24.4 Vaccine above). 

Varicella-like rashes at the injection site occurred rarely, in 0.1% of recipients; 

however, they were more common than in placebo recipients. Varicella-like 

rashes that were not localised to the injection site were also rare, and did not 

occur more often in vaccine compared with placebo recipients (0.1% in both 

groups). In the clinical trials in which rashes were analysed by PCR for VZV, the 

majority were due to wild-type virus; only 2 subjects were found to have rashes 

due to the Oka/Merck VZV vaccine strain (see also 4.24.4 Vaccine above). 

Fever >38.3°C was not seen more commonly in vaccine recipients, and occurred 

in


The product information for Zostavax states that the vaccine can be administered 

concurrently with inactivated influenza vaccine but not with 23vPPV. The ATAGI 

instead recommends that Zostavax may be administered concurrently with 

other vaccines as indicated. The ATAGI also recommends that if inadvertent 

concomitant administration of Zostavax and pneumococcal polysaccharide 

vaccine occurs, there is no need to revaccinate. 

The product information for Zostavax states that the safety and efficacy of 

Zostavax have not been established in adults with known HIV infection, 

with or without evidence of immunocompromise. The ATAGI recommends 

instead that Zostavax may be administered to HIV-infected persons without 

immunocompromise on a case-by-case basis, after seeking appropriate specialist 

advice, and following confirmation of pre-existing immunity to VZV. 

References 





PART 5 PASSIVE IMMUNISATION 

5.1 PASSIVE IMMUNISATION USING 

IMMUNOGLOBULIN PREPARATIONS 

Immunoglobulin preparations are used to provide passive immunisation, that 

is, the direct administration of antibodies to a non-immune person to provide 

immediate protection against infection or disease. 

Immunoglobulin infusions are also indicated for some immunocompromised 

persons who are antibody-deficient. In addition, immunoglobulins are also used 

in the treatment of a number of specific immune-mediated conditions in order 

to modulate the disease course. For further information regarding the use of 

intravenous immunoglobulins, refer to Criteria for the clinical use of intravenous 

immunoglobulin in Australia1 (www.nba.gov.au/ivig/index.html). 

It is important to recognise that separate immunoglobulin preparations 

are provided for intramuscular (IM) use and for intravenous (IV) use. 

These have different properties, and the preparations should be given 

only by the recommended route. Administration of IM immunoglobulin 

by the IV route will lead to severe reactions. For more information 

on intravenous immunoglobulin, refer to Criteria for the clinical use of 

intravenous immunoglobulin in Australia. 1 

There are two types of immunoglobulin: 

• normal human immunoglobulin 

• specific immunoglobulins. 

Normal human immunoglobulin (NHIG) is derived from the pooled plasma of 

blood donors. It contains antibody to microbial agents that are prevalent in the 

general population. 

Specific immunoglobulin preparations are obtained from pooled blood 

donations from patients convalescing from the relevant infection, donors recently 

vaccinated with the relevant vaccine, or those who, on screening, have been 

found to have sufficiently high antibody concentrations. These blood-derived 

specific immunoglobulins therefore contain concentrations of antibody to an 

individual organism or toxin at a higher titre than would be present in normal 

immunoglobulin. 

Donors of blood used for the production of NHIG and specific immunoglobulin 

products are screened, and the products are treated to minimise the risk of 


the immunoglobulin preparations containing HIV, hepatitis A, hepatitis B or 

hepatitis C viruses, or parvovirus. Two dedicated pathogen inactivation steps 

are incorporated into the manufacturing process. A pasteurisation step is usually 

used during manufacture. The risk of prion transmission remains theoretical (see 

www.transfusion.com.au/adverse_events/risks/estimates for further details). 

5.1.1 Availability of immunoglobulins 

CSL Limited supplies NHIG for IM use both directly to hospitals and to 

the Australian Red Cross Blood Service. Rabies immunoglobulin, tetanus 

immunoglobulin and botulism antitoxin can only be obtained by application 

tostate/territory health authorities. Respiratory syncytial virus (RSV) 

monoclonal antibody (Synagis; Abbott Australia) is available commercially. 

Other specific immunoglobulins (for hepatitis B, cytomegalovirus, tetanus and 

varicella-zoster), which are derived from Australian donated plasma, can be 

obtained only from the Australian Red Cross Blood Service with permission from 

an Australian Red Cross Blood Service medical officer. The Australian Red Cross 

Blood Service supplies these products free of charge. 

The Blood Service can be contacted by telephone nationally on 13 14 95; callers 

will then be connected to the relevant state or territory Australian Red Cross 

Blood Service branch. 

Individual state or territory contact numbers: 

• Australian Capital Territory 02 6206 6024 

• New South Wales 1300 478 348 

• Northern Territory 08 8928 5116 

• Queensland 07 3838 9010 

• South Australia 08 8422 1201 

• Tasmania 03 6230 6209 

• Victoria 03 9694 0200 

• Western Australia 08 9421 2869 


Store all immunoglobulins at +2°C to +8°C. Do not freeze. Protect from light. 

5.1.3 Normal human immunoglobulin for intramuscular use 

Normal human immunoglobulin (NHIG) is prepared by plasma fractionation 

of blood collected from volunteer donors by the Australian Red Cross Blood 

Service. It is a sterile solution of immunoglobulin, mainly IgG, and contains 

those antibodies commonly present in adult human blood. In Australia, NHIG is 

supplied as a 16% solution and made available through the Australian Red Cross 

Blood Service. 


5.1 PASSIVE IMMUNISATION 

USING IMMUNOGLOBULIN 

PREPARATIONS

• Normal Immunoglobulin-VF (human) (NHIG; for intramuscular use) 

– CSL Limited. 160 mg/mL immunoglobulin (mainly IgG) prepared 

from Australian blood donations. Supplied in 2 mL and 5 mL vials. 

Also contains glycine. 

Administration 

NHIG should be given by deep IM injection, using an appropriately sized 

needle. The NHIG should be introduced slowly into the muscle, to reduce pain. 

This product must not be administered intravenously because of possible severe 

adverse events, and hence an attempt to draw back on the syringe after IM 

insertion of the needle should be made in order to ensure that the needle is not 

in a small vessel. A special product for IV use (NHIG [intravenous]) has been 

developed for patients requiring large doses of immunoglobulin. For further 

information regarding the use of intravenous immunoglobulins, refer to Criteria 

for the clinical use of intravenous immunoglobulin in Australia. 1 

Recommendations 

Immunoglobulin preparations may be given to susceptible persons, as either 

pre-exposure or post-exposure prophylaxis, against specific infections. Normal 

pooled immunoglobulin contains sufficiently high antibody concentrations to 

be effective against hepatitis A and measles. Both hepatitis A and measles are 

notifiable diseases and further instructions about their management and the 

need for immunoglobulin can be found in national guidelines (www.health. 

gov.au/cdnasongs) and obtained from state/territory public health authorities 

(see Appendix 1 Contact details for Australian, state and territory government health 


The duration of effect of NHIG is dose-related. It is estimated that protection is 

maintained for 3 to 4 weeks with standard recommended doses of NHIG. 

Prevention of hepatitis A 

Hepatitis A vaccination (see 4.4 Hepatitis A) is recommended in preference to 

NHIG for post-exposure hepatitis A prophylaxis in persons ≥12 months of age 

who are immunocompetent. 

NHIG can be used when hepatitis A vaccine administration is contraindicated, 

in infants

Prevention of measles 

Measles vaccination (see 4.9 Measles) within 72 hours of case contact is 

recommended in preference to NHIG for post-exposure measles prophylaxis in 

many instances (see Table 4.9.2 in 4.9 Measles). 

NHIG contains a sufficiently high concentration of antibody against measles 

to be able to prevent or ameliorate infection in susceptible persons. NHIG 

should be given as soon as possible and within 7 days of exposure. 3 Passive 

protection, against measles particularly, may be required if the exposed person 

has an underlying immunological disorder (HIV/AIDS, immunosuppressive 

therapy), or to control an outbreak of measles among non-immunised persons, 

for example, in a childcare centre. The use of NHIG should be considered in 

HIV-positive persons exposed to a patient with measles. 

Immune deficiency 

Patients with abnormal antibody production (primary 

hypogammaglobulinaemia, multiple myeloma, chronic lymphoblastic 

leukaemia) usually receive therapy with the IV preparation of normal human 

immunoglobulin (NHIG [intravenous]). However, in some cases, NHIG is given 

by IM injection. The aim of therapy is to maintain serum IgG levels above 6 g/L. 

Some patients may receive the IM (160 mg/mL) preparation subcutaneously. For 

further information regarding the use of intravenous immunoglobulins, refer to 

Criteria for the clinical use of intravenous immunoglobulin in Australia. 1 

Note: Skin tests with NHIG should not be undertaken. The intradermal injection 

of concentrated immunoglobulin causes a localised area of inflammation, which 

can be misinterpreted as a positive allergic reaction. True allergic responses to 

NHIG given by IM injection are extremely rare. 

5.1.4 Specific immunoglobulins 

Specific immunoglobulins are used to protect against specific microbial 

agents such as hepatitis B, rabies and varicella-zoster viruses, and tetanus. 

Further instructions about the management of these diseases and the need 

for immunoglobulin should be obtained from state/territory public health 

authorities (see Appendix 1 Contact details for Australian, state and territory 

government health authorities and communicable disease control), and the national 

guidelines for management of disease from rabies and other lyssaviruses, 

including Australian bat lyssavirus (www.health.gov.au/cdnasongs). 

Specific immunoglobulins for botulism and cytomegalovirus (CMV) and 

a monoclonal antibody preparation for respiratory syncytial virus (RSV) 

are available as described below. Potential interactions, adverse events and 

storage requirements for these specific immunoglobulins are similar to those 

for NHIG (IM). 




PREPARATIONS

Hepatitis B specific immunoglobulin 

Hepatitis B specific immunoglobulin (HBIG) is prepared from plasma donated 

through routine blood bank collection. Stocks of HBIG are very limited, and use 

should be strictly reserved for those who are at high risk, such as babies born 

to mothers with chronic hepatitis B infection and non-immune persons who are 

exposed through occupational exposure to the blood of unidentified persons, or 

to persons who are chronically infected with hepatitis B or whose hepatitis status 

cannot be ascertained in time. 4 Requests for HBIG should be directed to the 

Australian Red Cross Blood Service in your state/territory (see 5.1.1 Availability of 

immunoglobulins above). 

See 4.5 Hepatitis B, ‘Management of infants born to mothers who are HBsAgpositive’ 

in 4.5.7 Recommendations and 4.5.11 Public health management of hepatitis B, 

for more information. 

Rabies specific immunoglobulin 

Rabies specific immunoglobulin (HRIG) is prepared from the plasma of 

hyperimmunised human donors. HRIG is only administered in persons who 

have not received a previous course of rabies vaccine. HRIG is also administered 

as part of the post-exposure prophylaxis used following potential Australian bat 

lyssavirus or other lyssavirus exposures in previously unvaccinated persons. 5 

A single dose of HRIG is given to provide localised anti-rabies antibody 

protection while the patient responds to the rabies vaccine. It should be given 

at the same time as the 1st post-exposure dose of vaccine (day 0). If not given 

with the 1st vaccine dose, it may be given up to day 7. From day 8 onwards, an 

antibody response to rabies vaccine is presumed to have occurred. 

The dose of HRIG is based on body mass and should be infiltrated in and 

around all wounds, using as much of the calculated HRIG dose as possible. 

The remainder of the HRIG dose should be administered intramuscularly at a 

site away from the injection site of rabies vaccine. 

See 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus) for more 

information. 

Varicella-zoster specific immunoglobulin 

Zoster immunoglobulin (ZIG) is highly efficacious, but is often in short supply. 

Normal high-titre zoster immunoglobulin is available from the Australian Red 

Cross Blood Service on a restricted basis for the prevention of varicella in highrisk 

subjects who report a significant exposure to varicella or herpes zoster. If ZIG 

is unavailable, large doses of NHIG can be given intramuscularly. This does not 

necessarily prevent varicella, but it lessens the severity of the disease. ZIG has no 

proven use in the treatment of established varicella or zoster infection. ZIG must 

be given early in the incubation period (within 96 hours of exposure), but may 

have some efficacy if administered out to as late as 10 days post exposure. ZIG 

is able to prevent or ameliorate varicella in infants

who are being treated with immunosuppressive therapy, and in pregnant 

women. 6,7 Patients suffering from primary or acquired diseases associated with 

cellular immune deficiency and those receiving immunosuppressive therapy 

should be tested for varicella-zoster antibodies following contact with a person 

with confirmed varicella. However, this should not delay ZIG administration, 

preferably within 96 hours and up to 10 days after initial exposure. 7 

See 4.22 Varicella for more information. 

Botulism antitoxin 

An equine antitoxin (derived from horses) has long been used in the treatment of 

adult botulism, but has not been shown to be effective in infant botulism. 8 Equine 

antitoxin is manufactured by pharmaceutical companies such as Chiron. Use in 

Australia is governed by the Therapeutic Goods Administration’s Special Access 

Scheme and physicians wishing to access this product should initially contact 

the relevant state/territory health authority (see Appendix 1 Contact details for 

Australian, state and territory government health authorities and communicable disease 

control). Hypersensitivity, presenting as fever, serum sickness or anaphylaxis, 

may follow the use of equine antitoxin. Skin testing followed by appropriate 

dosing should be administered according to the manufacturer’s instructions. 

An intravenous botulinum antitoxin, produced in the United States (BabyBIG; its 

sponsor is the Californian Department of Health Services), significantly reduces 

the duration of mechanical ventilation and hospitalisation in infant’s with 

botulism. 9 This product has been administered to Australian children with infant 

botulism. 10 It is not currently registered in Australia, but is registered by the 

United States Food and Drug Authority. Access to this product should be sought 

through the TGA’s Special Access Scheme. 

Cytomegalovirus immunoglobulin 

Cytomegalovirus (CMV) immunoglobulin is indicated for the prevention of CMV 

infection in immunocompromised persons at high risk of severe CMV disease, 

such as after bone marrow and renal transplants. 11-13 The treatment of established 

CMV infection and disease is primarily with antivirals, such as ganciclovir or 

vanciclovir, and there is contradictory evidence whether the addition of CMV 

immunoglobulin improves outcome. 11,13 

The product contains no antibacterial agent, and so it must be used immediately 

after opening. Any unused portion must be discarded. If the solution has been 

frozen, it must not be used. If the use of CMV immunoglobulin is contemplated, 

detailed protocols for administration and management of adverse events should 

be consulted, in addition to the product information. 

• CMV Immunoglobulin-VF (human) – CSL Limited. 55–65 mg/mL 

immunoglobulin (mainly IgG) prepared from human plasma with 

high levels of antibody to CMV. Single vials contain 1.5 million units 

of CMV immunoglobulin activity. Contains maltose. 




PREPARATIONS

Respiratory syncytial virus monoclonal antibodies 

A humanised mouse monoclonal antibody to respiratory syncytial virus (RSV) 

produced by cultured cells, palivizumab, is registered in Australia for prevention 

of serious lower respiratory tract disease caused by RSV in children at high 

risk of RSV disease. There is no consensus regarding the use of palivizumab 

in Australia. 14 This product is given by IM injection each month to children at 

high risk of severe RSV disease, during the seasonal period of exposure to RSV. 

Palivizumab has been found to reduce the absolute risk of hospitalisation from 

about 10% to about 5% for babies born prematurely, for babies with chronic 

neonatal lung disease, and also for babies with haemodynamically significant 

congenital heart disease, particularly when complicated by large left-to-right 

shunts leading to pulmonary hypertension. 14-22 It has not been shown to reduce 

the incidence of more severe outcomes, such as the need for ventilation, nor has it 

been shown to reduce mortality. 20,21 There are currently a number of clinical trials 

assessing a recombinant humanised antibody, motavizumab. 23 

• Synagis – Abbott Australia (palivizumab). Supplied in single-use 

vials of powder, to be reconstituted with sterile water for injection; 

50 mg in 4 mL vial; 100 mg in 10 mL vial. 

The dose of palivizumab is 15 mg/kg once a month, to be given by IM injection, 

preferably in the anterolateral thigh. Where possible, the 1st dose should be 

administered before commencement of the RSV season. 

Tetanus immunoglobulin 

Tetanus immunoglobulin (human) for intramuscular use 

Tetanus immunoglobulin (TIG) should be used for passive protection of 

persons who have sustained a tetanus-prone wound, where the person has not 

previously received 3 or more doses of a tetanus toxoid-containing vaccine or 

where there is doubt about their tetanus vaccination status. In persons who have 

a humoral immune deficiency, TIG should be provided after a tetanus-prone 

injury, regardless of the time since their last dose of tetanus-containing vaccine. 

TIG provides immediate protection that lasts for a period of 3 to 4 weeks. 24 For 

wounds not categorised as tetanus-prone, such as clean cuts, TIG is unnecessary. 

Detailed information on appropriate tetanus prophylaxis measures in wound 

management, including use of TIG, are outlined in Table 4.19.1 in 4.19 Tetanus. 

The recommended dose for TIG is 250 IU, to be given by IM injection as soon as 

practicable after the injury. If more than 24 hours have elapsed, 500 IU should be 

given. Because of its viscosity, TIG should be given to adults using a 21 gauge 

needle. For children, it can be given slowly using a 23 gauge needle. A tetanus 

toxoid-containing vaccine should be given at the same time in the opposite 


limb with a separate syringe, and arrangements should be made to complete 

the full course of tetanus toxoid-containing vaccinations. Details for accessing 

TIG should be obtained from the Australian Red Cross Blood Service (see 5.1.1 

Availability of immunoglobulins above). 

Tetanus immunoglobulin (human) for intravenous use 

• Tetanus Immunoglobulin-VF (human, for intravenous use) – CSL 

Limited. 55–65 mg/mL immunoglobulin (mainly IgG) prepared 

from human plasma containing high levels of antibody to the toxin 

of Clostridium tetani. Single vials containing 4000 IU human tetanus 

antitoxin. Contains maltose. 

Tetanus immunoglobulin for IV use (TIVG) is used in the management of clinical 

tetanus. 24 The recommended dose is 4000 IU, to be given by slow intravenous 

infusion. Detailed protocols for administration of this product and management 

of adverse events should be consulted if its use is contemplated. Requests for 

TIVG should be directed to the Australian Red Cross Blood Service in your state/ 

territory (see 5.1.1 Availability of immunoglobulins above). 

Diphtheria antitoxin 

Diphtheria antitoxin is prepared by immunising horses against the toxin 

produced by Corynebacterium diphtheriae. 

Advice should be sought with respect to diphtheria antitoxin access and dosage, 

and special arrangements made if hypersensitivity is suspected; this can be 

coordinated through the relevant state/territory health authority (see Appendix 1 



5.1.5 Potential interaction with vaccines 

Live attenuated viral vaccines 

Immunoglobulin preparations can interfere with the response to certain 

live attenuated viral vaccines by preventing vaccine virus replication after 

administration. Therefore, administration of live attenuated viral vaccines, 

such as measles and varicella vaccines (but not rotavirus, zoster or yellow 

fever vaccines), should be deferred, dependent on the clinical status of the 

patient, for at least 3 months after the IM administration of NHIG, and for at 

least 8 months after the administration of intravenous NHIG. 25 For detailed 

information on recommended intervals, see 3.3 Groups with special vaccination 

requirements, Table 3.3.6 Recommended intervals between either immunoglobulins or 

blood products and MMR, MMRV or varicella vaccination. For the same reason, if 

vaccination has occurred, administration of immunoglobulin products should be 




PREPARATIONS

deferred if possible until at least 3 weeks after a measles-containing or varicellacontaining 

vaccine has been given, unless it is essential that immunoglobulin be 

administered. However, Rh (D) immunoglobulin (anti-D) does not interfere with 

the antibody response to MMR- or varicella-containing vaccines and the two may 

be given at the same time in different sites with separate syringes or at any time 

in relation to each other (see 3.3 Groups with special vaccination requirements, Table 

3.3.6 Recommended intervals between either immunoglobulins or blood products and 

MMR, MMRV or varicella vaccination). 

Inactivated vaccines 

Inactivated vaccines, such as tetanus, hepatitis B or rabies, may be administered 

concurrently with immunoglobulin preparations, or at any time before or after 

receipt of immunoglobulin, using separate syringes and separate injection sites. 

This usually would occur when there has been actual or possible acute exposure 

to one of these infectious agents. 

5.1.6 Use in pregnancy 




Hypersensitivity reactions to immunoglobulin preparations occur rarely but 

may be more common in patients receiving repeated injections. Intramuscular 

immunoglobulins should not be administered to persons who have severe 

thrombocytopenia or any coagulation disorder that would contraindicate 

intramuscular injections. 

5.1.8 Adverse events and precautions 

Local tenderness, erythema and muscle stiffness at the site of injection occur very 

commonly (in over 10% of recipients) and may persist for several hours after 

injection. Systemic adverse events such as mild pyrexia, malaise, drowsiness, 

urticaria and angioedema are uncommon, occurring in fewer than 1% of 

recipients). Skin lesions, headache, dizziness, nausea, general hypersensitivity 

reactions and convulsions may occur rarely. 

Anaphylaxis following an injection of NHIG is very rare, but has been reported. 

Anaphylaxis is more likely to occur if NHIG for IM use is inadvertently given 

intravenously. 

References 




APPENDIX 1: CONTACT DETAILS FOR AUSTRALIAN, 

STATE AND TERRITORY GOVERNMENT 

HEALTH AUTHORITIES AND 

COMMUNICABLE DISEASE CONTROL* 

Australian Government health authorities 

Australian Government 02 6289 1555 

Department of Health 

Freecall: 1800 671 811 

and Ageing 


Australian Childhood 

Immunisation Register 

enquiries (ACIR) † 

1800 653 809 

ACIR email: acir@humanservices.gov.au 

ACIR Internet site: www.humanservices.gov.au/ 

customer/services/medicare/australian-childhoodimmunisation-register 

State and territory government health authorities 

Australian Capital 02 6205 2300 

Territory 

Immunisation Enquiry Line 

New South Wales 1300 066 055 

(to connect to your local Public Health Unit) 

Northern Territory 08 8922 8044 

Centre for Disease Control 

Queensland 13 HEALTH (13 4325 84) 

Contact your local Public Health Unit, details at 

www.health.qld.gov.au/cdcg/contacts.asp 

South Australia 1300 232 272 (8.30 am to 5.00 pm) 

Email: CDCB@health.sa.gov.au 

www.sahealth.sa.gov.au 

Tasmania 03 6222 7666 or 1800 671 738 

Victoria 1300 882 008 

Email: immunisation@health.vic.gov.au 

www.health.vic.gov.au/immunisation 

Western Australia 08 9388 4868 

08 9328 0553 (after hours Infectious Diseases 

Emergency) 

Email: cdc@health.wa.gov.au 

Contact details for communicable disease control 

Australian Capital 24-hour Communicable Disease Control Section: 

Territory 

02 6205 2155 

APPENDIX 1 465 

APPENDIX 1

New South Wales 1300 066 055 

(for connection to Public Health Unit) 

Northern Territory 8.30 am to 5.00 pm: 08 8922 8044 Centre for Disease 

Control 

(After hours Royal Darwin Hospital 08 8922 8888 for 

CDC on-call doctor) 

Queensland Contact your local Public/Population Health Unit, 

phone number listed in the White Pages 

South Australia 24 hour general enquiries line: 1300 232 272 

Tasmania 24 hour hotline: 1800 671 738 

Victoria 24 hour contact number: 1300 651 160 

Western Australia Perth Metropolitan area: 

08 9388 4852 

After hours/Emergency: 08 9328 0533 

Outside Perth Metropolitan area: 

Contact regional Population Health Unit 

* See also state/territory and Therapeutic Goods Administration (TGA) contact details for 

reporting AEFI in Table 2.3.3 Contact information for notification of adverse events following 

immunisation in 2.3.2 Adverse events following immunisation. 

† For more information on other registers, see 2.3.4 Immunisation registers. 


APPENDIX 2: LITERATURE SEARCH STRATEGY FOR 

THE 10TH EDITION OF THE HANDBOOK 

For each Handbook chapter, broad literature searches were conducted for the years 

since the last Handbook searches were performed, using up to 24 databases, listed 

in Table A2.1. The purpose of these searches was to ensure that NCIRS technical 

writers and ATAGI members had access to all relevant information from the 

latest medical literature to allow identification of important issues related to 

the updating of all Handbook chapters. In addition, since writing of the 9th 

edition of the Handbook, Selected Dissemination Information (SDI) searches were 

established to enable the ongoing collection of new relevant items on the search 

topics. This process used the same search strategies as previously described, 

which allowed consideration and inclusion of papers published since publication 

of the 9th edition Handbook. 

Table A2.1: Electronic databases searched for the 10th edition 

Electronic database Time period 

MEDLINE 2006–2011 

Cochrane Library – including Cochrane Database of Systematic 2006–2011 

Reviews, Database of Abstracts of Reviews of Effects, the 

Cochrane Central Register of Controlled Trials (CENTRAL), 

Methods Studies, the Health Technology Assessment Database, 

the NHS Economic Evaluation Database 

Cumulated Index Nursing & Allied Health Literature (CINAHL) 2006–2011 

(when required) 

Clinical Evidence 2006–2011 

EMBASE 2006–2011 

Australian focused Informit databases (AMI, APA-FT, APAIS, 2006–2011 

APAIS - Health, ATSIhealth, Ausport Med, CINCH - Health, 

DRUG, Health and Society, HIVA, Health Collection, Indigenous 

Collection, RURAL, SAGE) 

Searches were conducted using the electronic databases detailed in Table A2.1, 

with the search period from 2006 to October 2011, in order to retrieve items 

published since the searches completed for the 9th edition of the Handbook. The 

scope of the searches was broad, to ensure maximum retrieval and minimise 

the exclusion of items of interest. Previous Handbook searches were examined to 

determine the scope required for the new searches, and similar search strategies 


APPENDIX 2

were employed to ensure consistency of information retrieval, taking into 

account new terms added to the databases. 

Various search methods were tested, including ‘explode’ and ‘focus’ options. 

‘Exploded’ terms retrieve citations containing the term being searched and all 

the narrower related terms in the database. ‘Focus’ searches retrieve citations 

that have the search term as the major focus of the item. In the trial searches, 

some items of interest were missed using the ‘focus’ method, thus ‘exploded’ 

searches were utilised. All subheadings assigned to the subject headings were 

generally included. In general, the search strategy consisted of the disease topic 

and relevant vaccine terms, used in combination with the terms immunisation/ 

immunisation programs. Boolean operators AND, OR and NOT were used as 

appropriate. To ensure relevant and accurate retrieval, thesaurus terms (the 

controlled vocabulary terms used in the database) were used whenever possible. 

Keyword searching was used in the absence of an appropriate thesaurus term or 

if the database did not have thesaurus terms. To facilitate relevant retrieval and 

to limit what, in some instances, are very large search result sets, the following 

limits were applied to the disease topic searches: 

• Publication year – searches were generally limited to items published from 

2006–2011. 

• Language – searches were limited to items in English. 

• Human – items discussing only animals were removed. 

• In vitro – items discussing only in vitro studies were removed. 

• Abstracts – search results restricted to items containing abstracts. 

The search limits were slightly modified for some of the searches. For example, 

the Australian-specific searches did not have search results limited to abstract 

only, to ensure that all Australian items were retrieved. 

The ATAGI and NCIRS technical writers also identified, where possible, focused 

clinical questions for each of the Handbook chapters, in advance of conducting 

literature searches. Specific searches were conducted for these questions, both 

using the databases and time periods above, but also using additional databases, 

longer time periods and other strategies, such as clinical trial registries and 

handsearching, as necessary. 


APPENDIX 3: COMPONENTS OF VACCINES USED IN THE 

NATIONAL IMMUNISATION PROGRAM 

Please note that vaccine manufacture is subject to ongoing refinement and 

change. Therefore, the information in Table A3.1 may change. This information 

was current as of mid-2012 and has been sourced from the product information 

(PI) of each vaccine listed. The Therapeutic Goods Administration provides the 

most current versions of the PI and Consumer Medicines Information (CMI) 

documents for vaccines (and other medicines) on its website at www.tga.gov.au. 

For vaccines not listed in the National Immunisation Program, please refer 

to individual product information leaflet as supplied with the vaccine, or the 

Handbook chapter pertinent to that vaccine. 

None of the vaccines listed on the National Immunisation Program contains 

thiomersal. 

Table A3.1: Components of vaccines used in the National Immunisation Program 

Vaccine 

component* 

Vaccine brand † Antigen 

Albumin/serum Avaxim Hepatitis A (HAV) 

ProQuad Measles-mumps-rubella-varicella (MMRV) 

Quadracel Diphtheria-tetanus-acellular pertussisinactivated 

poliomyelitis (DTPa-IPV) 

Vaqta Hepatitis A (HAV) paediatric/adolescent 

Varilrix Varicella (VV) 

Varivax Refrigerated Varicella (VV) 

Aluminium Avaxim Hepatitis A (HAV) 

hydroxide Cervarix Human papillomavirus (HPV) 

Engerix-B Hepatitis B (HBV) adult and paediatric 

Havrix Junior Hepatitis A (HAV) paediatric 

H-B-Vax II Hepatitis B (HBV) adult and paediatric 

Infanrix IPV Diphtheria-tetanus-acellular pertussisinactivated 


Menjugate Syringe Serogroup C meningococcal conjugate 

(MenCCV) 

NeisVac-C Serogroup C meningococcal conjugate 

(MenCCV) 



APPENDIX 3

Vaccine 

component* 

Aluminium 

hydroxide/ 

phosphate 

Aluminium 

phosphate 

Borax/sodium 

borate 


Boostrix Diphtheria-tetanus-acellular pertussis 

(dTpa) reduced antigen 

Gardasil Human papillomavirus (HPV) 

Infanrix hexa Diphtheria-tetanus-acellular pertussishepatitis 

B-inactivated poliomyelitis- 


(DTPa-hepB-IPV-Hib) 

Adacel Diphtheria-tetanus-acellular pertussis 


Meningitec Serogroup C meningococcal conjugate 

(MenCCV) 

Prevenar 13 13-valent pneumococcal conjugate 

(13vPCV) 





Egg protein All influenza vaccines 

Agrippal Influenza 

Fluarix Influenza 

Fluvax Influenza 

Influvac Influenza 

Vaxigrip Influenza 

Formaldehyde Adacel Diphtheria-tetanus-acellular pertussis 


Agrippal Influenza 

Avaxim Hepatitis A (HAV) 

Boostrix Diphtheria-tetanus-acellular pertussis 






Haemophilus influenzae type b (DTPa-hepB- 

IPV-Hib) 









Vaccine 

component* 


Gelatin ProQuad Measles-mumps-rubella-varicella (MMRV) 


Gentamicin Fluarix Influenza 


Glutaraldehyde Adacel Diphtheria-tetanus-acellular pertussis 




Kanamycin Agrippal Influenza 

Mannitol Priorix Measles-mumps-rubella (MMR) 

Priorix-tetra Measles-mumps-rubella-varicella (MMRV) 

Monosodium ProQuad Measles-mumps-rubella-varicella (MMRV) 

glutamate (MSG) 


Neomycin Agrippal Influenza 


Fluvax Influenza 





IPV-Hib) 



Priorix Measles-mumps-rubella (MMR) 

Priorix-tetra Measles-mumps-rubella-varicella (MMRV) 





Varilrix Varicella (VV) 

Varivax Refrigerated Varivax Refrigerated 


Phenol Pneumovax 23 23-valent pneumococcal polysaccharide 

(23vPPV) 

Phenoxyethanol Adacel Diphtheria-tetanus-acellular pertussis 






APPENDIX 3

Vaccine 

component* 


Polymyxin Fluvax Influenza 




IPV-Hib) 





Polysorbate or Agrippal Influenza 

sorbitol Boostrix Diphtheria-tetanus-acellular pertussis 








IPV-Hib) 




Prevenar 13 13-valent pneumococcal conjugate 

(13vPCV) 

Priorix Measles-mumps-rubella (MMR) 

Priorix-tetra Measles, mumps, rubella and varicella 

(MMRV) 




RotaTeq Rotavirus 

Yeast Engerix-B Hepatitis B (HBV) adult and paediatric 


H-B-Vax II Hepatitis B (HBV) adult and paediatric 




IPV-Hib) 

* If the person to be vaccinated has had an anaphylactic reaction to any of the vaccine components, 

administration of that vaccine may be contraindicated. Specialist advice should be sought to 

identify the component and to review if the person can be vaccinated in future. 

† Please also refer to Appendix 4 Commonly asked questions about vaccination for more specific 

information about these various constituents. 


APPENDIX 4: COMMONLY ASKED QUESTIONS 

ABOUT VACCINATION 

This appendix contains information for providers to refer to when responding 

to questions and concerns about immunisation. It covers general questions on 

adult and childhood vaccination, including contraindications and precautions. 

In addition, a discussion on some of the more recent concerns about vaccination 

is included, covering issues relating to vaccine safety, vaccine content, 

immunisation as a possible cause of some illnesses of uncertain origin, and the 

need for vaccination. 

This appendix is divided into six sections: 

• General questions 

• Questions about contraindication and precautions 

• Questions about vaccine safety 

• Questions about vaccine content 

• Questions about the need for immunisation 

• Further information about vaccination 

A.4.1 General questions 

How does vaccination work? 

When a healthy person becomes infected with a virus or bacteria (also known 

as a pathogen), for example, the measles virus, the body recognises the virus as 

an invader, produces antibodies that eventually destroy the virus, and recovery 

occurs. If contact with the measles virus occurs again in the future, the body’s 

immune system ‘remembers’ the measles virus and produces an increase in 

antibodies to destroy this pathogen. 

Vaccination is the process that is used to stimulate the body’s immune system 

in the same way as the real pathogen or disease would, but without causing the 

symptoms of the disease. Most vaccines provide the body with ‘memory’ so 

that an individual does not get the disease if exposed to it (see 1.5 Fundamentals 

of immunisation). 

Vaccination conveys immunity to diseases by a process called active immunity, 

which can be achieved by administration of either inactivated (i.e. not live) or 

live attenuated pathogens or their products. Live vaccines are attenuated, or 

weakened, by growing the organism through serial culturing (or passaging) 

steps in various tissue culture media. Inactivation is usually done using 

heat or formalin (sometimes both). Inactivated vaccines may include the 

whole pathogen (such as oral cholera vaccine), the toxin produced by the 

pathogen (such as tetanus and diphtheria vaccines), or specific antigens (such 

as Haemophilus influenzae type b [Hib], meningococcal and pneumococcal 


APPENDIX 4

vaccines). In some cases, the antigen is conjugated (i.e. chemically linked) with 

proteins to facilitate the immune response. Inactivated viral vaccines may 

include whole viruses (such as inactivated poliomyelitis vaccine [IPV] and 

hepatitis A vaccines) or specific antigens (such as influenza and hepatitis B 

vaccines). Live attenuated viral vaccines include measles-mumps-rubella 

(MMR), varicella and yellow fever vaccines. 

Immunity can also be acquired passively by the administration of 

immunoglobulins, which are the same as antibodies (see 1.5 Fundamentals of 

immunisation). Such immunity is immediate and is dose-related and transient. 

For example, measles or hepatitis B immunoglobulin can be used promptly after 

exposure in an unimmunised person to help reduce the chance of getting measles 

or hepatitis B disease from the exposure. 

What is the correct site for vaccination? 

The top, outer part of the thigh (the vastus lateralis muscle) is the recommended 

site for injections for infants

When should preterm infants be vaccinated? 

Babies born at 65 years, regardless of the presence or absence of chronic illness, reduces 

mortality during the winter period in this age group (see 4.7 Influenza). The 

healthy elderly should also receive the 23-valent pneumococcal polysaccharide 

vaccine (see 4.13 Pneumococcal disease). 

Should adults receive pertussis (whooping cough) vaccine boosters? 

Yes. Two brands of acellular pertussis vaccines, both combined with tetanus and 

diphtheria antigens, are now available for adolescents and adults. dTpa vaccines 

are recommended in Australia for booster vaccination of individuals ≥10 years of 

age who have previously had a primary course of diphtheria-tetanus-pertussis 

vaccine. dTpa vaccines have a lower content of diphtheria and pertussis antigens 

than DTPa formulations for young children. 

A recent study showed that adults can be protected against pertussis after a 

single dose of dTpa. No recommendations about the need for further boosters 

using reduced antigen content formulation dTpa have been made at this time. 

A single dose of dTpa is recommended for the following groups, unless 

contraindicated or if they have already received a previous dose of dTpa in the 

last 10 years (or 5 years when specifically indicated, see 4.12 Pertussis): 

• adults working with young children; vaccination is especially recommended 

for those working in early childhood education and care 

• all healthcare workers 


APPENDIX 4

• adults planning a pregnancy, or both parents as soon as possible after 

delivery of an infant (preferably before hospital discharge) 

Pregnant women can also be vaccinated during the last trimester of 

pregnancy, as an alternative to getting vaccinated straight after delivery. This 

allows for antibodies to be transferred to the infant during the pregnancy 

– this particularly helps to protect the infant against pertussis. Other adult 

household members, grandparents and carers of young children should 

also be vaccinated. This recommendation is based on evidence from several 

studies of infant pertussis cases, in which family members, particularly 

parents, were identified as the source of infection in more than 50% of cases, 

and were the presumed source in a higher proportion. 

• any adult expressing an interest in receiving a booster dose of dTpa. 

Adults ≥50 years of age who have not previously received dTpa vaccine should 

also be offered vaccination (see 4.2 Diphtheria, 4.12 Pertussis or 4.19 Tetanus in this 

Handbook). 

Contraindications to the reduced antigen content formulation dTpa are discussed 

in 4.2 Diphtheria, 4.12 Pertussis and 4.19 Tetanus in this Handbook and include 

previous anaphylactic reaction to any vaccine component. 

If the patient has never received a primary course of dT, see 4.2 Diphtheria, 

4.12 Pertussis or 4.19 Tetanus in this Handbook. 

A person wants to receive his/her vaccines separately. Why can’t they do this? 

There is no scientific evidence or data to suggest that there are any benefits 

in receiving vaccines such as MMR as separate monovalent vaccines. Using 

the example of MMR vaccine, there is no individual mumps, measles or 

rubella vaccine approved for use in Australia. If these vaccines were to be 

administered individually, it would require three separate vaccines, which would 

unnecessarily increase discomfort for the child. In addition, if these monovalent 

vaccines were not given on the same day, they would need to be spaced 1 month 

or more apart, which would increase the risk of that person being exposed to 

serious vaccine-preventable diseases. A policy of providing separate vaccines 

would cause some people to not receive the entire course. Combination vaccines 

can offer a reduced amount of vaccine preparation to be injected overall, 

compared to three individual vaccine doses. 

Is vaccination compulsory? What happens if children do not get vaccinated? 

Vaccination is not compulsory in Australia. 

Eligibility for the Family Tax Benefit Part A supplement will require either that 

children are assessed as fully immunised or that the parent has obtained an 

appropriate medical or philosophical exemption. This replaced the Maternity 

Immunisation Allowance on 1 July 2012. 


If a parent decides not to have a child vaccinated and, if cases of certain vaccinepreventable 

diseases occur at that child’s day-care centre or school, the parent 

may, in some circumstances, be required to keep the unvaccinated child at home 

until the incubation period for that particular disease has passed or no further 

cases have occurred in that setting. 

A4.2 Questions about contraindications and precautions 

If a person has any concerns about whether to proceed with vaccination, they 

should be provided with appropriate information and encouraged to obtain 

expert advice from their usual immunisation provider or an immunisation 

specialist, if necessary. See Appendix 1 Contact details for Australian, state 

and territory government health authorities and communicable disease control for 

contact details. 

What are the absolute contraindications to childhood vaccination? 

True contraindications to vaccines are extremely rare (see relevant chapters), 

and include only anaphylaxis to any of the particular vaccine’s components, 

and anaphylaxis following a previous dose of that vaccine. Follow-up specialist 

medical advice should always be sought if any severe reaction or anaphylaxis has 

occurred following the administration of any vaccine(s). 

Note: Anaphylaxis following ingestion of eggs does not contraindicate MMR 

vaccine, as the vaccine viruses are not grown in eggs and the vaccine does not 

contain any egg protein (see 4.9 Measles). Many persons who have a history of a 

severe allergic reaction to eggs can also be vaccinated with influenza vaccine (see 

4.7 Influenza). 

Can someone who has had whooping cough (pertussis) still be vaccinated? 

Vaccination with pertussis vaccine in children, adolescents or adults who have 

had laboratory-confirmed pertussis infection is safe and is necessary, as natural 

immunity does not confer life-long protection. In particular, incompletely 

vaccinated infants

Should a person with an intercurrent illness be vaccinated? 

A child or adult with a minor illness (without systemic illness and with a 

temperature

Should vaccines be given to persons who have problems with their 

immune systems? 

Persons who are immunocompromised (from either a disease or medical 

treatment) should generally not be given live viral vaccines such as MMR, 

MMRV, varicella, zoster or rotavirus vaccines (see 4.9 Measles, 4.22 Varicella, 

4.24 Zoster and 4.17 Rotavirus). 

HIV-infected persons may be given MMR, varicella and zoster vaccines, 

provided they do not have severe immunocompromise (see 3.3 Groups with special 

vaccination requirements and Table 3.3.4 Categories of immunocompromise in HIVinfected 

persons, based on age-specific CD4 + counts and percentage of total lymphocytes). 

The close contacts of persons who are immunocompromised can be given live 

viral vaccines, except oral polio vaccine, which is no longer used in Australia. 

The rash seen in a small percentage of MMR vaccine recipients, usually between 

5 and 12 days after vaccination, is not infectious. Non-immune household 

contacts of persons who are immunocompromised should receive varicella 

vaccine. There is an almost negligible risk of transmitting varicella vaccine virus 

from a vaccine-related vesicular rash to contacts. However, vaccine-related 

rash occurs in 3 to 5% of vaccinated persons, either locally at the injection site 

or generalised, with a median of only 25 lesions. This small infection risk of the 

less virulent attenuated vaccine strain is far outweighed by the high risk of nonimmune 

contacts catching wild varicella infection and transmitting the virus 

to the immunocompromised household member via respiratory droplets or 

from the large number of skin lesions that occur with wild varicella infection (a 

median of 300 to 500 lesions). 

Live viral vaccines can be given to persons with leukaemia and other 

malignancies at least 3 months after they have completed chemotherapy, 

provided there are no concerns about their immune status. Such measures would 

normally be carried out under the supervision of the person’s oncologist (see 

3.3.3 Vaccination of immunocompromised persons). 

What vaccines should someone with HIV infection receive? 

Persons with HIV (human immunodeficiency virus) infection, especially 

children, should have all routine inactivated vaccines on the National 

Immunisation Program schedule. Varicella vaccine is contraindicated in 

persons with HIV who are significantly immunocompromised, as it can 

cause disseminated varicella infection. However, it may be considered for 

asymptomatic or mildly symptomatic HIV-infected children, after weighing 

up the potential risks and benefits. This should be discussed with the child’s 

specialist. MMR vaccine can be given to children with HIV, depending on their 

CD4 + counts (see ‘Should vaccines be given to persons who have problems 

with their immune systems?’ above). Persons with HIV infection should also 

be vaccinated against pneumococcal disease (see 4.13 Pneumococcal disease). 

Influenza vaccine is also recommended for HIV-infected persons. They should 


APPENDIX 4

not be given BCG, due to the risk of disseminated infection. More detailed 

information on the use of vaccines in persons with HIV is included in 3.3.3 

Vaccination of immunocompromised persons. 

Should chronically ill persons be vaccinated? 

In general, persons with chronic diseases should be vaccinated as a matter of 

priority, because they are often more at risk from complications from vaccinepreventable 

diseases. Annual influenza vaccine is highly recommended for 

chronically ill persons and their household contacts. 

Care is needed with the use of live attenuated viral vaccines in situations 

where the person’s illness, or its treatment, may result in impaired immunity. 

Advice may need to be sought on these patients to clarify the safety of live 

viral vaccine doses. 

Should children or household contacts be vaccinated while the child’s 

mother is pregnant? 

There is no problem with giving routine vaccinations to a child, or others, living 

in the same household with a pregnant woman. MMR vaccine viruses are not 

transmissible. Administration of varicella vaccine to household contacts of 

non-immune pregnant women is safe. Transmission of varicella vaccine virus 

is very rare. There is an almost negligible risk of transmitting varicella vaccine 

virus from a vaccine-related vesicular rash to contacts. However, vaccine-related 

rash occurs in 3 to 5% of vaccinated persons, either locally at the injection site or 

generalised, with a median of only 25 lesions. Furthermore, vaccinating the child 

of a pregnant mother will reduce the risk of her being infected by her offspring 

with the more virulent wild virus strain if she is not immune (see 3.3.2 Vaccination 

of women who are planning pregnancy, pregnant or breastfeeding, and preterm infants). 

Should persons with allergies be vaccinated? What precautions are required for 

atopic or egg-sensitive children or adults? 

Depending on the allergy identified, there often may not be a contraindication 

to vaccination. Specialist medical advice should always be sought in order to 

determine which vaccinations can be safely given. For example, a history of an 

allergy to antibiotics most commonly relates to β-lactam, or related antibiotics, 

and is not a contraindication to vaccines that contain neomycin, polymyxin B 

or gentamicin. Previous reactions to neomycin that only involved the skin 

are not considered a risk factor for a severe allergic reaction or anaphylaxis to 

vaccines manufactured with neomycin, since there are only trace amounts of 

this antibiotic in the final product (see 3.3.1 Vaccination of persons who have had an 

adverse event following immunisation). 

For other allergies, see Appendix 3, Components of vaccines used in the National 

Immunisation Program, and the relevant vaccine product information (PI) enclosed 

in the vaccine package. Unless the person being vaccinated has an allergy to a 

specific constituent of a vaccine (or has another contraindication), there is no 


eason not to vaccinate. Asthma, eczema and hay fever are not contraindications 

to any vaccine, unless the child/adult is receiving high-dose oral steroid therapy. 

Persons with egg allergies can receive MMR vaccines because the measles and 

mumps components of MMR vaccine do not contain sufficient amounts of egg 

ovalbumin to contraindicate MMR vaccination of people with egg allergy (even 

anaphylaxis) (see 3.3.1 Vaccination of persons who have had an adverse event following 

immunisation and 4.9 Measles). A simple dislike of eggs, or having diarrhoea or 

stomach pains after eating eggs, are not reasons to avoid MMR vaccination, and 

no special precautions are required in these circumstances. These persons can 

also have all other routine vaccines without special precautions. 

A history of anaphylaxis or allergy to egg had previously been considered an 

absolute contraindication to influenza vaccination, but there have now been 

a number of studies indicating that the majority of such persons can be safely 

vaccinated. 1,2 Given that there is still a small risk of anaphylaxis, it is essential 

that such persons are vaccinated in facilities with staff able to recognise and treat 

anaphylaxis. (See also 4.7 Influenza.) 

Yellow fever, Q fever and one of the available rabies vaccines contain a higher 

amount of egg albumin than is present in the currently available influenza 

vaccines. Persons with egg allergy requiring vaccination with either yellow fever, 

rabies or Q fever vaccines, should seek specialist immunisation advice from their 

state or territory health department. See also relevant chapters of this Handbook. 

Families with questions about allergies and vaccines are encouraged to discuss 

this with their immunisation service provider and, where necessary, seek 

referral to an immunologist to have any questions promptly answered to avoid 

unnecessary delays of vaccine doses or referral to a specialist immunisation 

clinic. Information on specialist immunisation clinics is available from your local 

state or territory health department. (See Appendix 1 for further details.) 

A4.3 Questions about vaccine safety 

Some people have concerns about immunisation. These mostly relate to whether 

the vaccine is safe and whether vaccines weaken the immune system. Providers 

should always listen to and acknowledge people’s concerns. Providers should 

discuss the risks and benefits of immunisation with parents/carers honestly and 

in a non-defensive manner. Parents/carers and adult vaccine recipients should 

receive accurate information on the risks from vaccine-preventable diseases and 

information about vaccine side effects and adverse events (see table Comparison 

of the effects of diseases and the side effects of NIP vaccines inside the back cover of 

this Handbook). The following section responds to some concerns raised about the 

safety of immunisation, and examines the scientific evidence in order to assist 

providers and parents in making an informed choice about the risks and benefits 

of vaccination. 


APPENDIX 4

How safe are vaccines? 

Before vaccines are made available for general use they are tested for safety 

and efficacy in clinical trials and then in large trials, otherwise known as phase 

II (2) and III (3) trials. All vaccines marketed in Australia are manufactured 

according to strict safety guidelines and are evaluated by the Therapeutic Goods 

Administration, to ensure they are efficacious and are of adequate quality and 

safety, before marketing approval is granted. 

After vaccines are introduced into vaccination schedules, they are subjected to 

continuing surveillance of efficacy and safety through trials and post-marketing 

surveillance. In Australia, there are regional and national surveillance systems 

actively seeking any adverse events following immunisation. This is necessary, 

as sometimes unexpected side effects occur after vaccines are registered for use. 

Australian reports on adverse events that occur following immunisation are 

published on a 6-monthly basis in the journal Communicable Diseases Intelligence 

(www.health.gov.au/internet/main/publishing.nsf/content/cda-pubs-cdicdiintro.htm). 

Can too many vaccines overload or suppress the natural immune system? 

No. Although the increase in the number of vaccines and vaccine doses given 

to children has led to concerns about the possibility of adverse effects of the 

aggregate vaccine exposure, especially on the developing immune system, there 

is not a problem. In day-to-day life, all children and adults confront enormous 

numbers of antigens, and the immune system responds to each of these in 

various ways to protect the body. Studies of the diversity of antigen receptors 

indicate that the immune system can respond to an extremely large number of 

antigens. In addition, the number of antigens received by children during routine 

childhood vaccination has actually decreased compared with several decades 

ago. This has occurred in spite of the increase in the total number of vaccines 

given, and can be accounted for by the removal of two vaccines – smallpox 

vaccine (which contained about 200 different proteins), and whole-cell pertussis 

vaccine (about 3000 distinct antigenic components) from routine vaccination 

schedules. In comparison, the acellular pertussis vaccine currently used in 

Australia has only 3 to 5 pertussis antigens. 3 

Do vaccines cause disease? 

Some studies have suggested a temporal link between vaccinations and 

certain medical conditions, such as asthma, multiple sclerosis and diabetes. 

The questions of a link are often made for a disease of unknown cause. The 

appearance of a certain medical condition after vaccination does not necessarily 

imply that they are causally related. Importantly, however, once an issue is raised 

it needs prompt research, discussion and then education to avoid creating a 

myth. In many cases, subsequent epidemiological studies have indicated that the 

association is due to chance alone. The following is a list of concerns that have 

been raised. 


Does MMR vaccine cause inflammatory bowel disease or autistic spectrum disorder? 

No. 

In 1998, Wakefield et al. (Royal Free Hospital, London) published a case-series 

study with 12 children suggesting that MMR vaccine caused inflammatory bowel 

disease (IBD), which then resulted in decreased absorption of essential vitamins 

and nutrients through the intestinal tract. They proposed that this could result in 

developmental disorders such as autism. The Lancet retracted this publication in 

2010 and the British Medical Council struck off the lead author in 2010, following 

the British General Medical Council’s Fitness to Practice Panel finding the author 

‘guilty of serious professional misconduct’. 

An extensive review published in 2004 by the Institute of Medicine (IOM), 

an independent expert body in the United States, concluded that there is no 

association between the MMR vaccine and the development of autism. A 2011 

update by the IOM continues to reject any causal association between MMR 

vaccine and autism (see www.iom.edu/vaccineadverseeffects). 

See 4.9 Measles for further information. There is also an MMR vaccine decision 

aid designed for parents available at www.ncirs.edu.au/decisionaid/index.html. 

Do childhood immunisations cause asthma? 

There is no evidence that vaccination causes or worsens asthma. It is especially 

important that children with asthma be vaccinated like other children, as 

catching a disease like whooping cough can make an asthma attack worse. 

Although influenza vaccine is not routinely recommended for all asthmatics, 

it is recommended for severe asthmatics, such as those requiring frequent 

hospitalisation (see 4.7 Influenza). 

Does influenza vaccine cause flu? 

No. It is not possible for influenza vaccine to cause ‘flu’ as it is not a live viral 

vaccine. (Note: a live attenuated influenza vaccine is used in some countries, but 

not in Australia.) As some people experience side effects such as a mild fever 

after the vaccine, it is understandable that they may confuse these symptoms 

with actually having the flu. In addition, the influenza vaccine is recommended 

to be given at the commencement of the flu season. Hence, it is possible that 

a person who has contracted, and is incubating, influenza during vaccination 

will mistakenly believe the vaccine to be causal. In addition, influenza vaccine 

is given at the very time of year when there are a lot of upper respiratory tract 

infections (URTIs) around. It is not uncommon for someone to attribute an URTI 

within a week of an influenza vaccine to the vaccine dose. Importantly, URTI 

symptoms occurring after influenza vaccine should not put people off having the 

vaccine the following year. 


APPENDIX 4

A4.4 Questions about vaccine content 4 

See also Table A3.1 Components of vaccines used in the National Immunisation 

Program in Appendix 3. Refer also to the product information (PI) or the 

consumer medicines information (CMI) for individual vaccines; both are 

available from the TGA website (www.tga.gov.au). 

Preservatives 

Preservatives are used to prevent fungal and or bacterial contamination of the 

vaccine. They include thiomersal, phenoxyethanol and phenol. 

Thiomersal 

Thiomersal (or thimerosal) is a compound that is partly composed of a form of 

mercury called ethylmercury. It has been used in very small amounts in vaccines 

for about 60 years to prevent bacterial and fungal contamination of vaccines. In 

the past, the small amount of thiomersal in vaccines was one of several potential 

sources of mercury. Diet (such as some seafood) and other environmental sources 

are also possible sources of mercury. Vaccines used in the past, such as DTP, 

contained only 25 µg of thiomersal per dose. 

Mercury causes a toxic effect after it reaches a certain level in the body. Whether 

or not it reaches a toxic level depends on the amount of mercury consumed and 

the person’s body weight; individuals with very low body weight are usually 

more susceptible to toxic effects from a certain intake of mercury. Thus, the 

possibility existed that vaccination of newborn babies, particularly those of very 

low birth weight, with repeated doses of thiomersal-containing vaccines might 

have resulted in levels of mercury above the recommended guidelines. 

Thiomersal was removed from vaccines in response to the above theoretical 

concern and to reduce total exposure to mercury in babies and young children in 

a world where other environmental sources may be more difficult to eliminate. 5-7 

Currently, all vaccines on the NIP for children and adolescents are free of 

thiomersal. 

Phenoxyethanol 

The aromatic ether alcohol, 2-phenoxyethanol, is used as a preservative in many 

vaccines, and also as a preservative in cosmetics. It is used in vaccines as an 

alternative preservative to thiomersal. 

Phenol 

Phenol is an aromatic alcohol used as a preservative in a few vaccines. 

Adjuvants 

Adjuvants are compounds used to enhance the immune response to vaccination 

and include various aluminium salts, such as aluminium hydroxide, aluminium 

phosphate and potassium aluminium sulphate (alum). A review of all available 

studies of aluminium-containing diphtheria, tetanus and pertussis vaccines 


(either alone or in combination) found no evidence that aluminium salts in 

vaccines cause any serious or long-term adverse events. 8 

Aluminium 

A small amount of aluminium salts has been added to some vaccines for 

about 60 years. Aluminium acts as an adjuvant, which improves the protective 

response to vaccination by keeping antigens near the injection site so they can 

be readily accessed by cells responsible for inducing an immune response. The 

use of aluminium in vaccines means that, for a given immune response, less 

antigen is needed per dose of vaccine, and a lower number of total doses are 

required. Although aluminium-containing vaccines have been associated with 

local reactions and, less often, with the development of subcutaneous nodules at 

the injection site, other studies have reported fewer reactions with aluminiumadsorbed 

vaccines than with unadsorbed vaccines. Concerns about the longerterm 

effects of aluminium in vaccines arose after some studies suggested a link 

between aluminium in the water supply and Alzheimer’s disease, but this link 

has never been substantiated. The amount of aluminium in vaccines is very 

small and the intake from vaccines is far less than that received from diet or 

medications such as some antacids. 9,10 

Additives 

Additives are used to stabilise vaccines in adverse conditions (temperature 

extremes of heat and freeze drying) and to prevent the vaccine components 

adhering to the side of the vial. 

Examples of additives include: 

• lactose and sucrose (both sugars) 

• sorbitol and mannitol (both sugar alcohols) 

• polysorbate 80, made from sorbitol and oleic acid (an omega fatty acid) 

• glycine and monosodium glutamate or MSG (both are amino acids or salts of 

amino acids) 

• gelatin, which is partially hydrolysed collagen, usually of bovine or porcine 

origin, although information on the source of gelatin is not routinely 

provided in the product information for all vaccines. 

Some members of the Islamic and Jewish faiths may object to vaccination, 

arguing that vaccines can contain pork products. However, scholars of 

the Islamic Organization for Medical Sciences have determined that the 

transformation of pork products into gelatin will sufficiently alter them, 

thus making it permissible for observant Muslims to receive vaccines, even 

if the vaccines contain porcine gelatin. Likewise, leaders of the Jewish faith 

have also indicated that pork-derived additives to medicines are permitted. 

Further information may be obtained from the following websites 


APPENDIX 4

www.vaccinesafety.edu/Porcine-vaccineapproval.htm and www.immunize. 

org/concerns/porcine.pdf 

• human serum albumin (protein). 

Manufacturing residuals 

Manufacturing residuals are residual quantities of reagents used in the 

manufacturing process of individual vaccines. They include antibiotics (such 

as neomycin or polymyxin), inactivating agents (e.g. formaldehyde) as well 

as cellular residuals (egg and yeast proteins), traces of which may be present 

in the final vaccine. Antibiotics are used during the manufacturing process to 

ensure that bacterial contamination does not occur; traces of these antibiotics 

may remain in the final vaccine. Inactivating agents are used to ensure that 

the bacterial toxin or viral components of the vaccine are not harmful, but will 

result in an immune response. Cellular residuals are minimised by extensive 

filtering. However, trace amounts may be present in the final product. The most 

commonly found residual is formaldehyde. 

Formaldehyde 

Formaldehyde is used during the manufacture of many vaccines. For example, 

with tetanus vaccines, formaldehyde is used to detoxify the tetanus toxin protein 

produced. The non-toxic protein, which becomes the active ingredient of the 

vaccine, is further purified to remove contaminants and any excess (unreacted or 

unbound) formaldehyde. The current standard applicable to vaccines for human 

use in Australia is less than 0.02% w/v of free formaldehyde. The maximum 

amount of free formaldehyde detected by the Therapeutic Goods Administration 

during testing of vaccines registered in Australia has been 0.004% w/v, which is 

well below the standard limit. 

Other ingredients and information about manufacturing 

Vaccines also may be made up in sterile water or sterile saline (salt-water). 

Some viruses used in vaccines require the use of ‘cell lines’ in which to grow the 

vaccine virus. The cell lines are not included as a component of the vaccine. Some 

of these cell lines (called human diploid cell lines – WI-38 and MRC-5) were 

originally derived from human fetal tissue in the 1960s. These cell lines have 

been growing under laboratory conditions for more than 40 years, and there has 

been no further fetal tissue obtained since the 1960s. The vaccines manufactured 

using viruses that were grown in these cell lines include rubella vaccine and 

MMR vaccine, hepatitis A vaccines, varicella vaccines, rabies vaccine and oral 

polio (Sabin) vaccine (no longer available in Australia). Many of these vaccines 

prevent severe disease in unborn babies and infants, including, most notably, 

rubella, which causes congenital rubella syndrome. 


A4.5 Questions about the need for immunisation 

Isn’t natural immunity better than immunity from vaccination? 

While vaccine-induced immunity may diminish with time without boosters 

(vaccine or contact with wild-type infection), ‘natural’ immunity, acquired by 

catching the disease, is usually life-long, with the exception of pertussis. The 

problem is that the wild or ‘natural’ disease has a higher risk of serious illness 

and occasionally death. Children or adults can be revaccinated (with some, but 

not all, vaccines) if their immunity from the vaccines falls to a low level or if 

previous research has shown that a booster vaccination is required for long-term 

protection. It is important to remember that vaccines are many times safer than 

the diseases they prevent. 

Diseases like measles, polio and diphtheria have already disappeared from 

most parts of Australia. Why do we need to keep vaccinating children against 

these diseases? 

Although these diseases are much less common now, they still exist. The 

potential problem of disease escalation is kept in check by routine vaccination 

programs. In countries where vaccination rates have declined, vaccinepreventable 

diseases have sometimes reappeared. For example, Holland has one 

of the highest rates of fully vaccinated people in the world. However, in the early 

1990s, there was a large outbreak of polio among a group of Dutch people who 

belonged to a religious group that objected to vaccination. While many of these 

people suffered severe complications like paralysis, polio did not spread into the 

rest of the Dutch community. This was due to the high rate of vaccination against 

polio, which protected the rest of the Dutch community. 

There have been recent outbreaks of whooping cough, measles and rubella 

in Australia, and a number of children have died. Cases of tetanus and 

diphtheria, although rare, still occur. Thus, even though these diseases are 

much less common now than in the past, it is necessary to continue to protect 

Australian children, so that the diseases cannot re-emerge to cause large 

epidemics and deaths. 

Also, many of the diseases against which we vaccinate our children are still 

common in other areas of the world. For example, measles still occurs in many 

Asian countries, where many people take holidays or travel for business. 

Therefore, it is possible for non-immune individuals to acquire measles 

overseas, and, with the speed of air travel, arrive home and be able to pass 

measles onto those around them if they are unprotected. Measles is highly 

infectious and can infect others for several hours after an infected person has 

left a room. Vaccination, while not 100% effective, can considerably minimise 

a person’s chance of catching a disease. The more people who are vaccinated, 

the less chance there is that a disease, such as measles, will spread widely in the 

community. This is referred to as ‘herd immunity’. 


APPENDIX 4

Why do some children get the disease despite being vaccinated? 

This is possible because a small proportion of those who are vaccinated will 

remain susceptible to the disease. However, in the cases in which illness does 

occur in vaccinated individuals, the illness is usually much less severe than in 

those who were not vaccinated. The protection provided by the same vaccine 

to different individuals can differ. For example, if 100 children are vaccinated 

with MMR, 5 to 10 of the 100 fully vaccinated children might still catch measles, 

mumps or rubella (although the disease will often be less severe in vaccinated 

children). If 100 children are vaccinated with a full schedule of pertussiscontaining 

vaccines, 20 of the children might still get whooping cough, but, 

once again, the disease is often less severe in these vaccinated children. To put 

it another way, if you do not vaccinate 100 children with MMR vaccine, and the 

children are exposed to measles, all of them will catch the disease with a risk 

of high rates of complications like pneumonia or encephalitis. The reason why 

fewer children become infected than these figures suggest is due to the high 

vaccine coverage rates in the community. If there are high coverage rates, there 

is less chance of contact with the infection and, although some children may be 

susceptible, they have a low chance of contact with the infection (this situation is 

also called ‘herd immunity’). 

What about homeopathic ‘immunisation’? 

Homeopathic ‘immunisation’ has not been proved to give protection against 

infectious diseases; only conventional vaccination produces a measurable 

immune response. The Council of the Faculty of Homeopathy, London, issued a 

statement in 1993, which reads: ‘The Faculty of Homeopathy, London, strongly 

supports the conventional vaccination program and has stated that vaccination 

should be carried out in the normal way, using the conventional tested and 

proved vaccines, in the absence of medical contraindications’. 11 

A4.6 Further information about vaccination 

More information about vaccination can be found in the following publications 

produced by the Australian Government Department of Health and Ageing: 

• Understanding childhood immunisation 

• Immunisation myths and realities – responding to arguments against immunisation: 

a guide for providers. 

The following two websites include further publications, fact sheets, etc. and are 

recommended for both immunisation service providers and the general public: 

• Immunise Australia website www.immunise.health.gov.au 

• The National Centre for Immunisation Research and Surveillance of Vaccine 

Preventable Diseases (NCIRS) website www.ncirs.edu.au. 

Also, check with your local state or territory Public Health Unit or local 

council, maternal child health nurse or public health vaccination clinic for more 

information (see Appendix 1 Contact details for Australian, state and territory 


References 




APPENDIX 5: GLOSSARY OF TECHNICAL TERMS 

Adjuvant 

a preparation added to a vaccine to improve the immune response to that vaccine 

Adverse event following immunisation (AEFI) 

an unwanted reaction following administration of a vaccine, which may or may 

not be caused by the vaccine; adverse events may be at the site of injection, or 

may be a general illness or a general allergic reaction 

Anaphylaxis 

a sudden and severe allergic reaction, which results in a serious fall in blood 

pressure and/or respiratory obstruction and may cause unconsciousness and 

death if not treated immediately 

Attenuation 

the process of modifying a virus or bacteria to reduce its virulence (diseaseinducing 

ability) while retaining its ability to induce a strong immune response 

(immunogenicity) 

Bacteria 

microorganisms that are smaller than a blood cell, but bigger than a virus; 

examples of bacterial infections are diphtheria, tetanus, pertussis, Hib and 

tuberculosis 

Brachial neuritis 

pain in the arm, causing persisting weakness of the limb on the side of 

vaccination 

Chronically infected 

formerly referred to as a ‘carrier’; a person who has an infection that, although 

not necessarily causing symptoms, may still be active and may spread to others; 

chronic infection may last for years; examples of infections that can result in 

chronically infected states are hepatitis B and typhoid 

Conjugate 

some bacterial vaccines (e.g. Hib, meningococcal and pneumococcal conjugate 

vaccines) are made from the chemical linking (conjugation) of a tiny amount of 

the ‘sugar’ (correctly known as the polysaccharide) that makes up the cell coat of 

the bacteria with a protein molecule, in order to improve the immune response to 

the vaccine 

Contraindication 

a reason why a vaccine or drug must not be given 

Corticosteroid 

a drug used to reduce inflammation and other immune responses 


APPENDIX 5

DT 

a vaccine that protects against diphtheria and tetanus. The acronym DT, 

using capital letters, signifies the child formulation of diphtheria and tetanuscontaining 

vaccine, and denotes the substantially larger amounts of diphtheria 

toxoid in this formulation than in the adolescent/adult formulation. 

dT 

reduced antigen content formulation of diphtheria-tetanus vaccine, which 

contains substantially lower concentrations of diphtheria toxoid, and 

approximately half the tetanus antigen content, than the child formulation 

(which is signified by using capital letters DT). This vaccine is most commonly 

administered to adolescents/adults. 

DTP/DTPa/DTPw 

a vaccine that protects against diphtheria, tetanus and pertussis (whooping 

cough). The DTP used in Australia and many other industrialised countries is 

DTPa, which contains an acellular pertussis component made of refined pertussis 

extracts instead of inactivated whole pertussis bacteria (DTPw). The acronym 

DTPa, using capital letters, signifies child formulations of diphtheria, tetanus 

and acellular pertussis-containing vaccines, and denotes the substantially larger 

amounts of diphtheria toxoid and pertussis antigens in these formulations than 

in the adolescent/adult formulations. 

dTpa 

reduced antigen content formulation of diphtheria-tetanus-acellular pertussis 

vaccine, which contains substantially lower concentrations of diphtheria toxoid 

and pertussis antigens, and approximately half the tetanus antigen content, than 

the child formulations (which are signified by using all capital letters [DTPa]). 

This vaccine is most commonly administered to adolescents/adults. 

Effectiveness 

the extent to which a vaccine produces a benefit in a defined population in 

uncontrolled or routine circumstances 

Efficacy 

the extent to which a vaccine produces a benefit in a defined population in 

controlled or ideal circumstances, for example, in a randomised controlled trial 

Encephalitis 

inflammation of the brain 

Encephalopathy 

a general term to describe a variety of illnesses that affect the brain, including 

encephalitis 

Endemic 

endemic infections are present all the time in a community 


Enzootic 

enzootic infections are present all the time in animals of a specific geographic 

area 

Epidemic 

epidemic infections are those that spread rapidly in a community; measles and 

influenza viruses are common causes of epidemics in Australia; small epidemics 

are often called outbreaks 

Extensive limb swelling 

swelling of the limb, with or without redness, which: 

» extends from the joint above to the joint below the injection site, or beyond 

a joint (above or below the injection site), or 

» results in the circumference of the limb being twice the normal size. 

Febrile 

related to a fever, as in febrile illness and febrile convulsions 

Hepatitis 

an inflammation of the liver; can be caused by viral infections 

Hypotonic-hyporesponsive episode (shock, collapse) 

the sudden onset of pallor or cyanosis, limpness (muscle hypotonia), and 

reduced responsiveness or unresponsiveness occurring after vaccination, 

where no other cause is evident, such as a vasovagal episode or anaphylaxis. 

The episode usually occurs 1 to 48 hours after vaccination and resolves 

spontaneously. 


the process of inducing immunity to an infectious agent by administering a 

vaccine 

Immunity 

the ability of the body to fight off certain infections; immunity can result from 

natural (‘wild’) infections or from vaccination 

Immunogenicity 

the ability (or the degree) to which a particular substance, in this context a 

vaccine, may provoke an immune response 

Immunoglobulin 

a protein extract from blood, sometimes called ‘antibody’, that fights off infection; 

injection of immunoglobulins provides temporary immunity against certain 

infections 


APPENDIX 5

Incubation period 

after a person is infected with bacteria or viruses, it often takes days or weeks 

for the infection to cause an obvious illness; the time between exposure to the 

infectious agent and development of the disease is called the incubation period 

Infection 

an infection occurs when bacteria or viruses invade the body; if the body cannot 

fight the infection, it may cause an illness 

Intradermal (ID) injection 

an injection into the surface layers of the skin; this is used for the administration 

of bacille Calmette-Guérin (BCG), the tuberculosis vaccine 

Intramuscular (IM) injection 

an injection into the muscle; vaccines are usually injected into a muscle of the 

upper outer thigh, or a muscle in the upper arm 

Intussusception 

when one portion of the bowel telescopes into the next portion of bowel, 

resulting in a blockage 

Invasive disease 

this term is often used when talking about pneumococcal or meningococcal 

disease. This term means that the bacteria (or germs) have been found in the 

blood, spinal fluid or another part of the body that would normally be sterile (or 

germ free). 

Jaundice 

yellow skin colour that may result from severe hepatitis 

Pandemic influenza 

a global epidemic that results when a new strain of influenza virus appears in the 

human population. It causes more severe disease in the population because there 

is little immunity to this new strain. 

Paracetamol 

a medicine that helps reduce fever; it may be given to minimise fevers following 

vaccination 

Pertussis 

whooping cough, an illness caused by a bacterium, Bordetella pertussis 

Polysaccharide 

a group of complex carbohydrates (sugars), which make up the cell coating 

present in some bacteria 

Polyvalent vaccine 

a combination vaccine that protects against more than one disease; examples are 

DTPa and MMR 


Rotavirus 

a virus that is a common cause of diarrhoea (and often vomiting as well) in 

young children. The diarrhoea can be severe in very young children, such that 

they may need intravenous fluids (i.e. through a vein in the arm) in hospital. 

Rubella 

a viral illness, sometimes also known as German measles 

Seizure 

a witnessed sudden loss of consciousness and generalised, tonic, clonic, tonic– 

clonic, or atonic motor manifestations. 

Types of seizures include: 

» febrile seizures; with fever >38.5°C 

» afebrile seizures; without fever 

» syncopal seizures; a syncope/vasovagal episode followed by seizure(s). 

Subcutaneous (SC) injection 

an injection into the tissue between the skin and the underlying muscle 

Syncope 

see vasovagal episode 

Thrombocytopenia 

platelet count

Virus 

a tiny living organism, smaller than a bacterium, that can cause infections; 

measles, rubella, mumps, polio, influenza and hepatitis B are examples of viruses 

Zoster 

an abbreviation for herpes zoster infection (also known as shingles); a painful 

rash and illness, caused by the varicella-zoster (chickenpox) virus 


APPENDIX 6: COMMONLY USED ABBREVIATIONS 

ABLV Australian bat lyssavirus 

ACIR Australian Childhood Immunisation Register 

ACT Australian Capital Territory 

ADRS Adverse Drug Reactions System 

AEFI adverse event following immunisation 

AIDS acquired immunodeficiency syndrome 

anti-HBe antibody to hepatitis B e antigen 

anti-HBc antibody to hepatitis B core antigen 

anti-HBs antibody to hepatitis B surface antigen 

AOM acute otitis media 

ASCIA Australasian Society of Clinical Immunology and Allergy 

ATAGI Australian Technical Advisory Group on Immunisation 

BCG bacille Calmette-Guérin 

CCID50 cell culture infectious dose 50% 

CDNA Communicable Diseases Network Australia 

CI confidence interval 

CIN cervical intraepithelial neoplasia 

CRS congenital rubella syndrome 

CSF cerebrospinal fluid 

DNA deoxyribonucleic acid 

DT diphtheria-tetanus vaccine for use in children (for further 

explanation of this term, see Appendix 5 Glossary of technical terms) 

dT diphtheria-tetanus vaccine for use in adults (for further 


DTPa diphtheria-tetanus-acellular pertussis vaccine (for further 


dTpa diphtheria-tetanus-acellular pertussis vaccine, reduced antigen 

content formulation (for further explanation of this term, see 

Appendix 5 Glossary of technical terms) 

DTPw diphtheria-tetanus-whole-cell pertussis vaccine (for further 


EIA enzyme immunoassay 

ELISA enzyme-linked immunosorbent assay 

FHA filamentous haemagglutinin 

FIM fimbriae (pertussis) 

GBS Guillain-Barré syndrome 

GP general practitioner 

GVHD graft-versus-host disease 

HAV hepatitis A virus 

HBcAg hepatitis B core antigen 

HBeAg hepatitis B e antigen 


APPENDIX 6

HBIG hepatitis B immunoglobulin 

HBsAg hepatitis B surface antigen 

HBV hepatitis B virus 

HCW healthcare worker 

HDCV human diploid cell vaccine (rabies) 

HepA hepatitis A vaccine 

HepB hepatitis B vaccine 

HHE hypotonic-hyporesponsive episode 

Hib Haemophilus influenzae type b 

Hib-MenCCV Haemophilus influenzae type b-meningococcal C conjugate vaccine 

HIV human immunodeficiency virus 

HPV human papillomavirus 

2vHPV bivalent HPV vaccine 

4vHPV quadrivalent HPV vaccine 

HRIG human rabies immunoglobulin 

HSCT haematopoietic stem cell transplant 

HZ herpes zoster 

ID intradermal 

IgA/G/M immunoglobulin A/G/M 

IM intramuscular 

IPD invasive pneumococcal disease 

IPV inactivated poliomyelitis vaccine 

IS intussusception 

ITP idiopathic thrombocytopenia purpura 

IU international units 

IV intravenous 

JE Japanese encephalitis 

LT-ETEC heat-labile toxin producing enterotoxigenic Escherichia coli 

MenCCV meningococcal serogroup C conjugate vaccine 

4vMenCV quadrivalent meningococcal conjugate vaccine 

4vMenPV quadrivalent meningococcal polysaccharide vaccine 

MMR measles-mumps-rubella 

MMRV measles-mumps-rubella-varicella 

NCIRS National Centre for Immunisation Research and Surveillance of 

Vaccine Preventable Diseases 

NHIG normal human immunoglobulin 

NHMRC National Health and Medical Research Council 

NHVPR National HPV Vaccination Program Register 

NIP National Immunisation Program 

NSW New South Wales 

NT Northern Territory 

NTHi non-typeable Haemophilus influenzae 

OMP outer membrane protein 


OPV oral poliomyelitis vaccine 

PCECV purified chick embryo cell vaccine (rabies) 

PCR polymerase chain reaction 

7vPCV 7-valent pneumococcal conjugate vaccine 



PEP post-exposure prophylaxis 

pH1N1 pandemic influenza A(H1N1)pdm09 

PHN post-herpetic neuralgia 

PI product information 

PreP pre-exposure prophylaxis 

23vPPV 23-valent pneumococcal polysaccharide vaccine 

PRN pertactin 

PRP polyribosylribitol phosphate 

PRP-OMP PRP conjugated to the outer membrane protein of Neisseria 

meningitidis 

PRP-T PRP conjugated to tetanus toxoid 

PT pertussis toxoid 

Qld Queensland 

RCT randomised controlled trial 

RIG rabies immunoglobulin 

RNA ribonucleic acid 

SA South Australia 

SC subcutaneous 

SCID severe combined immunodeficiency 

SIDS sudden infant death syndrome 

SOT solid organ transplant 

SSPE subacute sclerosing panencephalitis 

Tas Tasmania 

TB tuberculosis 

TCID50 tissue culture infectious dose 50% 

TGA Therapeutic Goods Administration 

TIG tetanus immunoglobulin 

TST tuberculin skin test 

Vic Victoria 

VLP virus-like particle 

VNAb (rabies) virus neutralising antibody 

VPD vaccine-preventable disease 

VV varicella vaccine 

VZV varicella-zoster virus 

WA Western Australia 

WHO World Health Organization 

ZIG zoster immunoglobulin 


APPENDIX 6

APPENDIX 7: OVERVIEW OF VACCINE AVAILABILITY 

IN AUSTRALIA 

Table A7.1 provides an overview of key dates when vaccines first came into 

widespread use in Australia. This table provides only some dates; for specific 

details on vaccine registration, funding, recommendations and program use, 

please see complete information in the ‘NCIRS Vaccination History Tables’ 

available from the NCIRS website (www.ncirs.edu.au/immunisation/history/ 

index.php). These tables, listed by vaccine type, provide a summary of the 

significant events in vaccination practice in Australia, particularly for vaccines 

used in population-based immunisation programs. Additional information 

regarding vaccines available in each jurisdiction can also be sought from your 

local state or territory Immunisation Department. 

Table A7.1: Key dates when vaccines first came into widespread use in Australia 

Year Vaccine 

1945 Tetanus toxoid 

1953 Diphtheria-tetanus-pertussis, whole-cell (DTPw) 

1956 Poliomyelitis (Salk) (inactivated poliomyelitis vaccine [IPV]) 

1966 Poliomyelitis (Sabin) (live attenuated oral poliomyelitis vaccine [OPV]) 

1970 Measles 

1971 Rubella 

1975 Child diphtheria-tetanus (CDT) 

1982 Adult diphtheria-tetanus (ADT) 

1982 Measles-mumps 

1982 Hepatitis B (hepB) (serum-derived vaccine) 

1987 Hepatitis B (recombinant vaccine) 

1989 Measles-mumps-rubella (MMR) 

1993 Hib (Haemophilus influenzae type b) 

1994 Hepatitis A 

1997 Diphtheria-tetanus-pertussis, acellular (DTPa) 

1999 Influenza 

1999 23-valent pneumococcal polysaccharide (23vPPV) 

2000 DTPa-hepB 

2000 Hib(PRP-OMP)-hepB 

2001 7-valent pneumococcal conjugate (7vPCV) 


Year Vaccine 

2003 Varicella 

2003 Meningococcal C conjugate 

2004 Diphtheria-tetanus-pertussis, acellular; reduced antigen content 

formulations (dTpa and dTpa-IPV) 

2005 Pentavalent and hexavalent combination DTPa vaccines (DTPa-hepB-IPV- 

Hib; DTPa-IPV; DTPa-hepB-IPV; DTPa-IPV-Hib) 

2007 Human papillomavirus (HPV) 

2007 Rotavirus 



2013 Measles-mumps-rubella-varicella (MMRV) 


APPENDIX 7

INDEX 

Italicised numbers indicate tables 

2-phenoxyethanol, in vaccines, 19, 484 

7vPCV (7-valent pneumococcal conjugate 

vaccine), 45, 56–60, 108, 194, 320, 321, 322, 

328, 333 

adverse events following immunisation 

(AEFI), 335 

pneumococcal disease epidemiology, 

318–319 


vaccine), 8, 14, 43, 46, 52–53, 56, 58, 60, 68, 

194, 319, 320. see also pneumococcal disease 


(AEFI), 335 

dosage and administration, 323–324 

and Indigenous children, 108 

pregnancy and breastfeeding, 334 

route of vaccine administration, 68–69 

transport, storage and handling, 323 

vaccination recommendations, 324–333 


vaccine), 8, 14–15, 43, 46, 62, 68, 105, 149, 151, 

156, 160, 160–161, 163–164, 174, 194, 251, 257, 

319–322 


(AEFI), 334–335 

catch-up vaccination, 52–53, 57–58 

catch-up vaccination guidelines for 

children with medical condition 

associated with an increased risk, 59–60 


children without medical condition 

associated with an increased risk, 56 

catch-up vaccination schedules for those 

≥10 years of age, 63–64 


and Indigenous children, 108 

and influenza vaccination, 257 

minimum acceptable vaccine dose 

intervals, 50 

number of vaccine doses for children, 49 

precautions, 334 

pregnancy and breastfeeding, 136, 334 


variations from product information, 

336–337 

23vPPV (23-valent pneumococcal 

polysaccharide vaccine), 15, 62, 105, 110, 137, 

143, 149, 151, 156, 160, 161, 163, 163–164, 321, 

321–322, 455, 471 


(AEFI), 336 


children with medical condition 

associated with an increased risk, 59–60 





intervals, 50 


pneumococcal disease epidemiology, 

318–319 



A 

abattoir workers. see animals, persons working 

with 

abbreviations list, 495–497 

Aboriginal and Torres Strait Islander people, 

35, 104–112 

additional recommended vaccines, 105 

adults, 109–111 

catch-up vaccination, 57–58 

changes to recommendations in the 10th 

edition of the handbook, 9, 12, 15 

children, 49, 50, 106–108 

Haemophilus influenzae type b (Hib), 

106–107, 192 

hepatitis A, 47, 107, 198–199, 201, 203, 206 

hepatitis B, 109, 209, 221 

human papillomavirus (HPV), 233 

influenza, 108, 109–110, 246, 254 

Japanese encephalitis, 111 

pneumococcal disease, 52–53, 108, 110–111, 

133, 318–319, 321, 324–325, 327–328, 329, 

330–332 

rotavirus, 373 

rubella, 111, 390 

service delivery to, 112 

tuberculosis, 106, 408, 412 

Act-HIB, 51, 55, 192 


variations from product information, 197 

active immunisation, 18–20 

acute febrile illness, vaccination 

recommendations, 31 

acute otitis media (AOM). see otitis media 

acute systemic illness, vaccination 


Adacel, 123, 185, 306, 400 

vaccine components, 470–471 

variations from product information, 189, 

315, 406–407 

Adacel Polio, 185, 189, 306, 315, 340, 344, 400 


additives, in vaccines, 485–486 

adjuvants, in vaccines, 19, 484–485 

administration of vaccines, 65–84 

changes in the 10th edition of the 

handbook, 9 

equipment, 65–69

identifying the injection site, 79–82 

injection techniques, 71–73 

multiple vaccine injections, 83–84 

occupational health and safety issues, 65 

positioning, 75–78 

preparation, 70 

recommended injection sites, 73–74 

route, 67–69 

adolescents 

catch-up vaccination schedules, 61–62, 

63–64 

diphtheria, 186 

hepatitis B, 213, 214, 214–215, 220 


injection sites, 74 

measles, post-exposure prophylaxis, 281 

measles, vaccination, 273 


mumps, 299–300 

pertussis, 306 

positioning for vaccination, 78 

Q fever, 348–350 

rabies, 356–357 

rubella, 389–390 

tetanus, 400, 401 

varicella, 425, 428–429, 429 

adrenaline 

autoinjectors, 90–91 

doses, 90 

in management of anaphylaxis, 89–91 

ADT Booster, 123, 184, 400 


406 

adults 

catch-up vaccination schedules, 61–64, 

63–64 

cholera, 179 

consent on behalf of an adult lacking 

capacity, 27 

diphtheria, 186–187 

hepatitis A, 202 

hepatitis B, 213–214, 214–215, 220–224 

human papillomavirus (HPV), 238–239 

Indigenous persons, 109–111 

influenza, 251 



measles, vaccination, 273 


mumps, 299–300 

pertussis, 306, 308–309 

pneumococcal disease, 326–327, 330–333 

poliomyelitis, 342 

positioning for vaccination, 78 

Q fever, 348–350 

rabies, 356–357 


tetanus, 400, 402, 403–404 

vaccination status and history, 40 

varicella vaccination, 425, 429 

and varicella vaccination, 434 

yellow fever vaccination, 444 

and zoster, 446–447, 447–448 

zoster vaccination, 450–453 

adverse events following immunisation (AEFI), 

9, 18, 21–23, 85–97, 481–482 

anaphylaxis and vasovagal episodes, 87–91 

cholera, 181 

common events, 91 


events without causal link, 94 

Haemophilus influenzae type b (Hib), 196 


hepatitis B, 227–228 

human papillomavirus (HPV), 240, 241–242 

influenza, 249, 257–258 

Japanese encephalitis, 265–266 

measles, 278–280 

meningococcal disease, 292 

mumps, 301 

mumps vaccination, 301 

passive immunisation, 458, 464 

pertussis, 311, 312–313 

pneumococcal disease, 335–336 


poliomyelitis vaccination, 343 

Q fever, 351–352 

rabies and other lyssaviruses (including 

Australian bat lyssavirus), 370–371 

reporting of, 94–97 

rotavirus, 381–382 

rubella, 394 

state and territory contact information, 96 

tetanus, 405 

tuberculosis (TB), 414 

typhoid, 422 

uncommon or rare events, 92–93 

vaccination of persons who have had an 

AEFI, 130–133 

varicella, 433–435 

yellow fever, 443, 444–445 

zoster (herpes zoster), 448, 454 

Aedes aegypti, 439. see also yellow fever 

Africa 

cholera, 176 

hepatitis B, 118, 209, 221 


measles, 268, 269 

meningococcal disease, 120, 284 

migrants to Australia from, 174 



Australian bat lyssavirus), 354, 361 

rubella, 390 

INDEX 501 

INDEX

travel to, 116 

tuberculosis, 408 

typhoid, 416, 418 

yellow fever, 114, 439–440, 443 

agammaglobulinaemia, vaccination 


aged care facility residents, and influenza 

vaccination, 255 

agricultural staff and students, vaccination 


Agrippal, 247, 470–472 


AIDS, and zoster vaccination, 450–451 

albumin, in vaccines, 469 

alcoholism, 13 


and pneumococcal disease, 327 

and tuberculosis (TB), 408 

allergies, 32, 131–133, 480–481. see also egg 

allergies 

aluminium hydroxide, in vaccines, 19, 469–470, 

484–485 

aluminium phosphate, in vaccines, 470, 

484–485 

Americas 

cholera, 176 

hepatitis B, 118, 209 




rubella, 390 


yellow fever, 114, 116, 439, 440 

anaesthesia, vaccination recommendations 

before or after, 168 

anal cancer, 233 

anaphylaxis, 37, 43, 87–91, 92–93, 131–132 

adrenaline use, 89–91 

and cholera vaccination, 180 

clinical features, 88 

contraindications to vaccination, 37 

and diphtheria vaccination, 187, 190 

and Haemophilus influenzae type b (Hib) 

vaccination, 196, 197 

and hepatitis A vaccination, 206 

and hepatitis B vaccination, 227, 230 

and human papillomavirus vaccination, 

241–242 

and immunoglobulin injection, 464 

an influenza vaccination, 256–257, 258 

and Japanese encephalitis vaccination, 265 

and measles vaccination, 275, 279 

and meningococcal vaccination, 292 

and pertussis vaccination, 312 

and pneumococcal vaccination, 334 

and poliomyelitis vaccination, 343 

response kit, 24 


and rotavirus vaccination, 379 

and rubella vaccination, 392 

and tetanus vaccination, 404, 405 

and tuberculosis vaccination, 414 

and typhoid vaccination, 421 

vaccination recommendations, 32 


and yellow fever vaccination, 443, 444 

and zoster vaccination, 453 

animals, persons working with 

influenza vaccination, 255 

Q fever vaccination, 346, 348 


anogenital warts, 233–234 

anterolateral thigh injection site, 79–80 

antibiotics, and typhoid vaccination, 421 

antiviral medication, and zoster vaccination, 

454 

armed forces 

hepatitis B, 223 

typhoid, 420 


Asia 

cholera, 176 


hepatitis B, 118, 209, 221 


Japanese encephalitis, 113–114, 119, 

259–260, 263–264 

measles, 268, 269, 487 





rubella, 390 

tick-borne encephalitis, 121 


typhoid, 122, 416 

yellow fever, 439 

aspirin therapy 


and measles vaccination, 278 

and varicella vaccination, 433, 438 


asplenia, persons with, 10 

Haemophilus influenzae type b (Hib) 

vaccination, 195–196, 197 

meningococcal vaccination, 52, 136, 137, 

153, 283, 290, 291, 294 

and pneumococcal disease, 317, 326–327, 

332 

vaccination recommendations, 35, 62, 

161–164, 163–164 

Australian bat lyssavirus (ABLV), 353, 354. see 

also rabies and other lyssaviruses (including 

Australian bat lyssavirus)

Australian Capital Territory 


(AEFI) notification, 95, 96 

age of consent, 26 

Australian Red Cross Blood Service, 457 

government health authority and 

communicable disease control contact 

details, 465–466 

pneumococcal vaccination, 52, 56 

Australian Childhood Immunisation Register 

(ACIR), 39, 89–99, 174, 268, 465 

Australian Government Department of Health 

and Ageing, 4, 22, 122, 129, 442, 465, 488 

Australian Government Department of 

Immigration and Citizenship (DIAC), 

information about refugee immunisation, 173 

Australian Influenza Vaccine Committee, 248 

Australian Q Fever Register, 102, 349 


Australian Technical Advisory Group on 

Immunisation, xi–xii, 1, 3 

autism, 94, 280, 483 

autoimmune conditions, vaccination 


Avaxim, 199 

lower age limits for, 127 

recommended doses and schedules, 125, 

202 


B 

BabyBIG, 461 

bacille Calmette-Guérin vaccine. see BCG 

vaccine 

bats. see animals, persons working with 

BCG (bacille Calmette-Guérin vaccine) vaccine, 

16, 37, 67, 409–410 


(AEFI), 414 



and HIV-infected persons, 159 

and immunocompromised persons, 

147–148 

for Indigenous neonates, 104, 105, 106 


and pregnancy, 139, 142, 413 

recipients of, further vaccination 


route of vaccine administration, 68–69, 72 

and subsequent live vaccines, 33, 271, 276, 

298, 300, 376, 388, 393 


and travellers, 121 

vaccination procedures, 411 



bleeding disorders, vaccination 

recommendations, 35, 168 

blood product recipients, 33, 166–167 






zoster, 454 

body-piercers. see skin penetration procedures 

bone marrow malignancies, and tuberculosis 


Boostrix, 185, 306, 400 

doses and route of administration, 123 

vaccine components, 470 


190, 315–316, 406–407 

Boostrix-IPV, 185, 307, 341, 400 

doses and route of administration, 123 


190, 315–316, 344, 407 

borax, in vaccines, 470 

Bordetella parapertussis, 302. see also pertussis 

Bordetella pertussis, 302, 398. see also pertussis 

botulism antitoxin, 461 

availability, 457 

brachial neuritis, 93, 489 

and diphtheria vaccination, 187–188 


and tetanus vaccination, 405 

breast cancer patients, injection sites, 74 

breastfeeding 


and diphtheria vaccination, 187 




and human papillomavirus (HPV) 



and Japanese encephalitis vaccination, 

264–265 


and meningococcal vaccination, 291–292 

and mumps vaccination, 300 

and pertussis vaccination, 310–311 


and Q fever vaccination, 350–351 

and rabies vaccination, 370 


and rubella vaccination, 391–392 




and varicella vaccination, 430–431 

and yellow fever vaccination, 443 


INDEX 503 

INDEX

C 

cancer patients. see oncology patients 

cardiac disease 



carers 


measles vaccination, 274 


catch-up vaccination, 8, 38–64 

for 13vPCV and 23vPPV in children with a 

medical condition(s) associated with an 

increased risk of invasive pneumococcal 

disease, 59–60 

for 13vPCV in Indigenous children in NT, 

Qld, SA or WA, 57–58 

for 13vPCV in non-Indigenous children, 

and Indigenous children in the ACT, 

NSW, Tas and Vic, who do not have any 

medical condition(s) associated with an 

increased risk of invasive pneumococcal 

disease, 56 

children


vaccines, 177–178 


chronic cardiac disease, and pneumococcal 

disease, 327 

chronic conditions, vaccination 

recommendations, 35, 165 

chronic inherited metabolic diseases, and 


chronic liver disease patients 



pneumococcal disease, 327 

chronic lung disease, and pneumococcal 

disease, 327 

chronic neurological conditions, and influenza 


chronic renal failure, and influenza vaccination, 

254 

chronic respiratory conditions, and influenza 


Clostridium tetani, 51, 397, 405, 463. see also 

tetanus 

CMV Immunoglobulin-VF (human), 461 

co-administration of vaccines, 8. see also 

simultaneous injections 

cholera, 179 

Haemophilus influenzae type b (Hib), 194, 203 




influenza, 92, 251 


measles, 271 


MMR (measles-mumps-rubella) vaccines, 

271, 301 

MMRV (measles-mumps-rubella-varicella) 

vaccines, 271, 301 

mumps, 298 

pneumococcal disease, 323–324, 335 


rubella, 388 

typhoid, 419 

varicella, 427 


zoster (herpes zoster), 449–450, 453 

cochlear implants, and pneumococcal disease, 

326 

cold chain, 25 

complement component disorders, and 

meningococcal vaccination, 291 

congenital cellular immunodeficiencies, and 

tuberculosis vaccination, 413 

congenital limb malformation, injection sites, 

74 

congenital rubella syndrome (CRS), 384 

congenital varicella syndrome, 423 

consent, 25–28 

on behalf of a child or adolescent, 26–27 

on behalf of an adult lacking capacity, 27 

evidence of, 27–28 

for school-based vaccination programs, 28 

contraindications to vaccination, 37. see also 

under individual disease names 

commonly asked questions about, 477–481 

false contraindications, 37, 38 

convulsions, persons with family history, and 


correctional facility inmates, 174 

hepatitis A, 204, 205 

hepatitis B, 216, 223, 224 


correctional facility staff 

measles, 274 


corticosteroid administration, 478. see also 

immunosuppressive therapy 

and live attenuated vaccines, 146 

and measles vaccination, 275–276, 277 


and rabies post-exposure prophylaxis, 362 





Coxiella burnetii, 345, 347. see also Q fever 

cuddle position, 75, 77 

cytomegalovirus immunoglobulin, 461 


D 

day-care workers. see early childhood 

education and care workers 

deltoid injection site, 81–82 

detention centre staff, vaccination 


developmental disability, persons with 

hepatitis A vaccination, 204 

hepatitis B vaccination, 223 

diabetes, type 1, vaccination recommendations, 

165 

diabetes mellitus 





(AEFI), 187–188 

bacteriology, 182 


handbook, 11–12 



dosage and administration, 186 

INDEX 505 

INDEX

epidemiology, 182 


public health management, 188 

recommendations, 186–187 





188–190 

diphtheria antitoxin, 463 

diphtheria-tetanus (dT) vaccine, 184, 400, 490 


(AEFI), 405 


≥10 years of age, 63 

vaccination recommendations, 401–402, 

403–404 

diphtheria-tetanus-acellular pertussis (dTpa 

and DTPa) vaccines, 183, 303, 304–307, 

398–400, 490 


(AEFI), 312–313 

catch-up vaccination for children, 46, 50, 51 


≥10 years of age, 63 



minimum acceptable age for the 1st vaccine 

dose, 46 


intervals, 50 



and pregnancy, 135, 310–311 


401, 403–404 

diphtheria-tetanus-whole-cell pertussis 

(DTPw) vaccine, 303, 490 


(AEFI), 312 

diseases. see vaccine-preventable diseases 

distraction technique, 70 

documentation of vaccination, 97 

when incomplete, 40 

dosage. see also under individual disease names, 

valid dose determination, 41 

dose intervals, minimum. see minimum 

acceptable dose intervals for children 

Down syndrome, 8 

and influenza vaccination, 13, 252 


drugs, persons who inject, 36, 61 

hepatitis A, 198, 204, 205 

hepatitis B, 209, 210, 216, 222, 224, 225 

tetanus, 403 



dT vaccines. see diphtheria-tetanus vaccine 

(dT) vaccines 

DTPa-containing vaccine. see diphtheriatetanus-acellular 

pertussis (dTpa and DTPa) 

vaccines 

dTpa-containing vaccines. see diphtheriatetanus-acellular 

pertussis (dTpa and DTPa) 

vaccines 

Dukoral, 177 




E 

early childhood education and care workers 


measles, 274 


vaccination recommendations, 169, 170 


eculizumab treatment, and meningococcal 


effectiveness of vaccines, 20–21 

efficacy of vaccines, 20–21 

egg allergies, 10, 131, 132–133, 481 

and influenza vaccination, 132, 256–257, 258 


and Q fever vaccination, 351 


egg protein, in vaccines, 19, 470, 486 

embalmers 



emergency workers 



Engerix-B, 160, 211, 212 

dosage and administration, 123, 217 


vaccination schedule, 214 

vaccination schedule, accelerated, 215, 216 

vaccine components, 469, 472 

enteric fever. see typhoid 

epiglottitis, 191 

erythematous skin reactions, 351 

Essen, 363 

essential services personnel, influenza 


Europe 





measles, 268 

mumps, 295 

poliomyelitis, 338

abies and other lyssaviruses (including 


tick-borne encephalitis, 114, 121 

tuberculosis, 408, 409 

F 

failure of vaccines, 20–21 

fainting. see vasovagal episode 

fatal disseminated infection, and tuberculosis 


febrile convulsions, 92–93, 94 

and influenza vaccination, 244, 249, 257 




febrile seizures, 493 



and pneumococcal vaccination, 334, 335 

and rubella vaccination, 388–389 


Fluad, 248 

Fluarix, 247 


Fluvax, 92, 248 


(AEFI), 249, 257 



Fluvax Junior, 92 


(AEFI), 257 

formaldehyde, in vaccines, 19, 470, 486 

funeral workers, vaccination recommendations, 

172 

G 

Gardasil, 234, 235 



gastroenteritis, and rotavirus vaccination, 380 

gelatin, in vaccines, 19, 471, 485 

gentamicin, in vaccines, 471 

glossary of technical terms, 489–494 

glutaraldehyde, in vaccines, 471 

glycine, in vaccines, 485 

Guillain-Barré syndrome (GBS), 93 


and meningococcal vaccination, 292, 293 


H 

haematopoietic stem cell transplant (HSCT) 

recipients 






156–157 

zoster, 447 

haemodialysis patients, hepatitis B vaccination, 

222 

haemoglobinopathies 


and pneumococcal vaccination, 326–327 

Haemophilus influenzae, 191, 192 

Haemophilus influenzae type b (Hib), 191–197 


(AEFI), 196 


catch-up vaccination for children, 46, 49, 

50, 51, 54–55 


handbook, 12 


co-administration with other vaccines, 203 



epidemiology, 191–192 


and Indigenous children, 106–107 

interchangeability of vaccines, 194 


dose, 46 


intervals, 50 


and persons with asplenia, 162, 163–164 


and preterm infants, 144 







Haemophilus influenzae type b–meningococcal C 

combination vaccine (Hib-MenCCV), 12, 14, 

52, 192–193, 285–286, 288. see also Haemophilus 

influenzae type b (Hib); meningococcal 

disease 

Hajj pilgrimage, 116, 120, 129, 290. see also 

Middle East 

HALO principle, 61–63 

Havrix 1440, 199 


Havrix Junior, 199 

recommended dose and schedule, 202 

recommended lower age limit, 127 


HBsAg-positive mothers, hepatitis B 


INDEX 507 

INDEX

H-B-Vax II, 212, 217 

dosage and administration, 123, 211, 222 

vaccination schedule, 156, 214 


healthcare workers 



measles, 274 







hepatitis A 


(AEFI), 207 


handbook, 12 



dosage and administration, 201–203, 202 



and Indigenous persons, 107, 203 



dose, 47 


intervals, 50 






serological testing for immunity, 206 





virology, 198 

hepatitis A/hepatitis B combination vaccines, 

205, 217, 224 

hepatitis A/typhoid combination vaccines, 

205–206 



(AEFI), 227–228 

booster doses, 224–225 


children, 51 




handbook, 12 


combination vaccines, 224 





hepatitis B immunoglobulin (HBIG), 219 

higher risk groups, 220–224 


and Indigenous persons, 109, 221 



dose, 46 


intervals, 50 

non-responders to vaccination, 226 




public health management, 228–229 





and travellers, 117–118 

vaccination schedules, 214–215 

vaccination schedules, accelerated, 215–216 


virology, 208 

hepatitis B immunoglobulin (HBIG), 229, 460 


and HBsAg-positive mothers, 219 

Hepatitis B Immunoglobulin-VF, 229 

hepatitis C patients, hepatitis B vaccination, 

222 

herpes zoster (HZ), 423. see also zoster (herpes 

zoster) 


Hiberix, 51, 193 



Hirschsprung’s disease, and rotavirus 


history of vaccination. see vaccination status 

and history 

HIV-infected persons. see also 


categories of immunocompromise, 158 


measles, 277 

rubella, 392 


typhoid, 421 




zoster, 447, 450–451, 454 

homeless people, influenza vaccination, 255 

homosexuals. see men who have sex with men 

HPV Register. see National HPV Vaccination 

Program Register (NHVPR)

HPV Vaccination Program, 234 

human diploid cell vaccine (HDCV), 68, 133, 

355, 356, 358, 359, 363, 365, 370 


human papillomavirus (HPV) 


(AEFI), 241–242 

catch-up vaccination schedules, 63–64 


handbook, 13 

clinical features, 231–232 





female vaccination, 237–238 

and HIV-infected persons, 159–160 


male vaccination, 238–239 

National HPV Vaccination Program 

Register (NHVPR), 101–102 







virology, 231 

human rabies immunoglobulin, 357, 362–363 

and post-exposure prophylaxis, 360–368 

and pregnancy and breastfeeding, 370 

hypopituitarism, vaccination 


hypotonic-hyporesponsive episode (HHE), 93 

and pertussis vaccination, 312–313 

I 

immigrants. see migrants to Australia 

immunisation, commonly asked questions, 

487–488 

active, 18–20 

passive, 17, 18, 456–464 

immunisation handbook 

background, 1–2 

development, 3–4 

fundamentals of immunisation, 18–23 

how to use, 5–6 

literature search strategy, 467–468 

what’s new, 7–17 

Immunisation History Statements, 99–100 

immunisation registers, 85–97 

immunocompromised persons. see also 

immunocompromising conditions 



influenza, 253–254 

measles, 275–276, 277 

rotavirus, 373, 379, 380–381 

rubella, 392 

typhoid, 421 

vaccination recommendations, 32, 145–165 

vaccination recommendations for 

household members of, 36, 148 

varicella, 430, 431 


zoster, 435–436, 447, 450, 451–452, 453 

immunocompromising conditions. see 

also immunocompromised persons; 


asplenia, 161–164 

haematopoietic stem cell transplant (HSCT) 

recipients, 161–164 

HIV-infected persons, 158–160 

persons with autoimmune and other 

chronic conditions, 165 

solid organ transplant (SOT) recipients, 

150–154 

immunoglobulin administration, and zoster 


immunoglobulin recipients. see normal human 

immunoglobulin (NHIG) recipients 

immunoglobulin treatment. see normal human 

immunoglobulin (NHIG) treatment 

immunoglobulins, 456–464 

adverse events, 464 


contraindications to use, 464 

for intramuscular use, 457–459 

normal human immunoglobulins (NHIG), 

456 

specific immunoglobulins, 456–457, 

459–463 



and rabies post-exposure prophylaxis, 362 




and zoster immunoglobulin, 435–436, 461 


Imogam Rabies Pasteurized, 355 

Imojev, 37, 111, 260–261 


(AEFI), 265–266 

booster doses, 264 

dosage and administration, 125, 262–263 


pregnancy and breastfeeding, 140, 264–265 

impaired immunity. see immunocompromising 

conditions 

impaired immunity, persons with. see 


INDEX 509 

INDEX

inactivated poliomyelitis vaccine (IPV), 

68–69, 118, 138, 156, 194, 339, 341. see also 

poliomyelitis 

Indigenous community workers, vaccination 


Indigenous persons. see Aboriginal and Torres 

Strait Islander people 

indurated lesions, 352 

Infanrix hexa, 51, 67, 183, 193, 195, 211, 305, 

339–340, 342, 399 


transport, storage and handling, 185, 194, 

217, 307, 341, 401 




190, 197, 230, 314, 316, 343, 405, 407 

Infanrix IPV, 184, 305, 340, 342, 399 



190, 314, 316, 343–344, 406, 407 

infants 

cholera, 186 



hepatitis B, 212, 214–215, 218–220, 219 




measles, vaccination, 271–272 


multiple vaccine injections, 83 

mumps, 299 

pertussis, 307–308, 309–310 


positioning for vaccination, 75–76, 77 

rabies, 356–357 

rotavirus, 377–378, 380–381 

rubella, 388 

tetanus, 401 


vaccination recommendations for parents, 

grandparents and carers, 36, 309 

yellow fever, 443, 445 

zoster immunoglobulin, 435–436 

influenza 


(AEFI), 257–258 


handbook, 13 





and egg allergies, 256–257 





and immunocompromised persons, 145 

and Indigenous persons, 108, 109–110, 254 

national notification and hospitalisation 

rates, 245 


precautions, 256–257 








vaccination and egg allergies, 132 



virology, 243 

influenza pandemic, 245–246 

Influvac, 247 


Influvac Junior, 247 

injecting drug users. see drugs, persons who 

inject 

injection of vaccines, 66–67 

injection site abscess 

and Q fever vaccination, 351 


injection site nodules, 91 

injection site reactions, 63, 74 




265–266 


and tetanus vaccination, 404–405 


and zoster vaccination, 448, 451, 452, 454 

injection sites 

adolescents, 74 

adults, 74 

breast cancer or lymphoedema patients, 74 

children, 73–74 

children in spica casts, 74 

children with congenital limb 

malformation, 74 

identification of, 79–82 

infants, 73 

multiple injections, 83–84 

injection techniques 

intradermal injection, 72 

intramuscular injection, 71–73 

subcutaneous injection, 72 

inmates of correctional facilities. see 

correctional facility inmates 

Intanza 9 mg, 68, 72, 248, 249 

Intanza 15 mg, 68, 72, 248, 249

interferon-gamma release assays (IGRAs), 410 

International Certificate of Vaccination or 

Prophylaxis against yellow fever, 440, 

441–442 

international travel. see travellers 

interruption to a vaccination, 73, 376, 383 

intracranial shunts, and pneumococcal disease, 

326 

intradermal injection technique, 72 

intradermal vaccines, 68–69 

intramuscular (IM) injection technique, 71 

intramuscular (IM) injection vaccines, 68–69 

intussusception (IS), and rotavirus vaccination, 

16, 22, 93, 374–375, 379, 381–382 

invasive pneumococcal disease (IPD). see 

pneumococcal disease 

IPOL, 69, 339, 341 


(AEFI), 343 





J 



(AEFI), 265–266 


handbook, 13 






and Indigenous persons, 111 


pregnancy and breastfeeding, 138, 140, 

264–265 







virology, 259 

JEspect, 68, 111, 260, 261–262 


(AEFI), 266 


lower age limits for, 127–128 





K 

kanamycin, in vaccines, 471 

keloid formation, and tuberculosis vaccination, 

411, 414 

L 

laboratory personnel 





lactose, in vaccines, 19, 485 

leprosy, and tuberculosis vaccination, 412 

leukaemia. see immunocompromised persons 

lifestyle vaccination requirements, 36 

limb swelling, and pertussis vaccination, 308, 

312, 491 

Liquid PedvaxHIB, 51, 55, 193 


live attenuated vaccines, 32, 37. see also 

Japanese encephalitis; MMR (measlesmumps-rubella) 

vaccine; MMRV (measlesmumps-rubella-varicella) 

vaccine; rotavirus; 

tuberculosis; typhoid; varicella; yellow fever; 

zoster (herpes zoster) 

and anaesthesia or surgery, 168 

and autoimmune conditions, 165 

and blood products, 150, 166 

and corticosteroids, 165 

and haematopoietic stem cell transplant 

(HSCT) recipients, 155 


and immunocompromised persons, 32, 

35–36, 142, 145, 146, 147–148 

and immunoglobulins, 150, 463–464 

and migrants to Australia, 174 

and normal human immunoglobulin 

(NHIG) recipients, 166 

and pregnancy, 33, 34, 133–134, 142 

livestock workers. see animals, persons 

working with 

local adverse event. see injection site reactions 

long-term care facility workers 


measles, 274 



lymphoedema patients, injection sites, 74 

lymphoid system malignancies, and 

tuberculosis vaccination, 413 

lymphoma. see immunocompromised persons 

Lyssavirus, 353. see also rabies and other 

lyssaviruses (including Australian bat 

lyssavirus) 

lyssaviruses. see rabies and other lyssaviruses 

(including Australian bat lyssavirus) 

INDEX 511 

INDEX

M 

malabsorption syndromes, and rotavirus 


malnutrition, and tuberculosis vaccination, 413 

mannitol, in vaccines, 19, 471, 485 

Mantoux test. see tuberculin skin test 

manufacturing residuals, in vaccines, 486 

measles 


(AEFI), 278–280 





contraindications to vaccination, 275–276 



global elimination, 268 


and other live attenuated parenteral 

vaccines, 276 





serological testing for immunity, 274–275 

transport, storage and handling of vaccines, 

270 




virology, 267 

measles control campaigns, 268, 296, 384 

measles-mumps-rubella vaccine. see MMR 

(measles-mumps-rubella) vaccine 

measles-mumps-rubella-varicella vaccine. see 


vaccine 

meat industry workers. see animals, persons 

working with 

Medicare Online, 98 

men who have sex with men, 174 



human papillomavirus (HPV), 232, 239 

Menactra, 285–286 


(AEFI), 292 




Mencevax ACWY, 287 


Meningitec, 285 




meningitis. see Haemophilus influenzae type b 

(Hib); meningococcal disease 

meningococcal C conjugate vaccines 

(MenCCV), 284, 285, 289–290. see also 

meningococcal disease 



dose, 47 


meningococcal disease, 283–294 


(AEFI), 292 



children, 52 




handbook, 14 





and haematopoietic stem cell transplant 

(HSCT) recipients, 157 




intervals, 50 


and persons with asplenia, 161–162, 

163–164 




and solid organ transplant (SOT) recipients, 

153 

transport, storage and handling, 287–288 


vaccines, 69, 285–287 

variations from vaccine product 

information, 293–294 

Menitorix, 51, 52, 55, 193, 285 

transport, storage and handling, 194, 288 

Menjugate Syringe, 285 




Menomune, 287 




Menveo, 286 




variations from product information, 293

mercury, in vaccines. see thiomersal, in vaccines 

Mérieux Inactivated Rabies Vaccine, 133, 355. 

see also human diploid cell vaccine (HDCV) 


metabolic diseases 



Middle East 


meningococcal disease, 116, 120, 290 

pilgrimage to Mecca (Hajj and Umra), 116, 

120, 129, 290 

migrants to Australia, 173–174 

from hepatitis B endemic countries, 12, 

209, 221 

immunisation schedules for other 

countries, 39 

and travel, 127 


typhoid, 417 

military personnel. see armed forces 

minimum acceptable age for the 1st dose of 

vaccination, 8, 41, 46–48 

minimum acceptable dose intervals for 

children, 41, 42, 50 

MMR (measles-mumps-rubella) vaccines, 

269–270, 296–297, 386, 425 

and adults and adolescents, 273 


(AEFI), 278–280, 301, 394 


children, 52 



and children, 272–273, 299 

co-administration with other vaccines, 

271, 301 





and infants, 274, 299 



dose, 47 


intervals, 50 


precautions, 276–278, 393–394 

pregnancy and breastfeeding, 140, 275, 300, 

391–392 

recommended intervals between 

immunoglobulins or blood products and 

the vaccine, 167 


vaccination and egg allergies, 132–133 

vaccination of suspected rubella contacts, 

394–395 




396 



M-M-R II, 68, 269, 297, 386 

dosage and administration, 124, 271, 298, 

387 


387 



vaccines, 68–69, 270, 296–297, 386, 424, 425, 

426 

and adults and adolescents, 273, 299–300, 

428–429 


(AEFI), 278–280, 301, 394 


children, 52 

and children, 272–273, 299, 428 


271, 301 

dosage and administration, 271, 387–388, 

427 


precautions, 276–278, 393–394 

pregnancy and breastfeeding, 140, 275, 300, 

391–392 

recommended intervals between 

immunoglobulins or blood products and 

the vaccine, 167 


vaccination of suspected rubella contacts, 

394–395 




396, 437–438 



Modified Essen, 363 

monosodium glutamate (MSG), in vaccines, 

471, 485 

Morbillivirus, 267. see also measles 

multi-dose vials, 67 

multiple sclerosis, vaccination 


mumps, 295–301 


(AEFI), 301 




INDEX 513 

INDEX









recommended doses and schedules, 

299–300 




vaccines, 296 


virology, 295 

Mycobacterium africanum, 408. see also 

tuberculosis 

Mycobacterium bovis, 408, 409. see also 

tuberculosis 

Mycobacterium canetti, 408. see also tuberculosis 

Mycobacterium leprae, 410, 412. see also 

tuberculosis 

Mycobacterium microti, 408. see also tuberculosis 

Mycobacterium tuberculosis, 408. see also 

tuberculosis 

Mycoplasma pneumoniae, 302. see also 

tuberculosis 

N 

National Centre for Immunisation Research 

and Surveillance of Vaccine Preventable 

Diseases (NCIRS), 3, 27, 467, 467–468, 488, 

498 

National HPV Vaccination Program Register 

(NHVPR), 9, 40, 101–102, 174 

National Immunisation Program (NIP), 2, 3, 

31, 67 


catch-up worksheet for children

Northern Territory 

ACIR reporting, 98 


(AEFI) notification, 96 






hepatitis A, 105, 107, 199, 201, 203 


HPV reporting, 101 


NT Immunisation Register, 103 

pneumococcal disease, 15, 52, 57–58, 105, 

108, 110, 318, 321, 324, 329, 330 


nursing home staff 



O 

obese persons, 72 


occupational health and safety issues, 65 

administration of vaccines, 65 

occupational risks, 2, 11, 29, 36, 61, 62, 115, 

130, 169–173, 371. see also under individual 

occupations 

hepatitis A, 199, 204, 205 

hepatitis B, 223–224, 225, 460 

measles, 274 


Q fever, 346, 348 


Australian bat lyssavirus), 371 

rubella, 396 



Oceania, 113, 118, 439. see also Pacific Islands 

oncology patients, vaccination 


OPV, 53, 339, 341, 376 

oral live attenuated typhoid vaccine. see also 

Vivotif Oral 


(AEFI), 422 






oral poliomyelitis vaccine. see OPV 

oral vaccines, 37, 68–69, 73, 123–126. see also 

under rotavirus, typhoid and cholera 

oropharyngeal cancer, 233 

otitis media, 108, 191, 244, 267, 317, 321. see also 


P 

Pacific Islands. see also Oceania 




rubella, 390 


palivizumab, 462 

Papua New Guinea 

Japanese encephalitis, 113–114, 119, 259, 263 



typhoid, 122, 416 

paracetamol, 85, 91, 292 

and fits, 478 

measles, 278, 279 


paralytic polio. see poliomyelitis 

parenteral Vi polysaccharide vaccines, 418. see 

also typhoid, vaccines 


(AEFI), 422 





passive immunisation, 18, 456–464. see also 

immunoglobulins 

availability of immunoglobulins, 457 


handbook, 17 

normal human immunoglobulin for 

intramuscular use, 457–459 

potential interactions with vaccines, 

463–464 

specific immunoglobulins, 459–463 


Pediacel, 51, 184, 193, 305–306, 340, 399 


197, 315, 344, 406 

pertussis, 302–316 


(AEFI), 312–313 







interval between vaccines, 310 

pregnancy and breastfeeding, 310–311 





vaccination of contacts of cases, 314 


INDEX 515 

INDEX


314–316 

Pharmaceutical Benefits Advisory Committee 

(PBAC), 3 

Pharmaceutical Benefits Scheme (PBS), 3 

phenol, in vaccines, 471, 484 

phenoxyethanol, in vaccines, 471, 484 

pilgrims attending Hajj in Saudi Arabia, 116, 

120, 129, 290 

plumbers, vaccination recommendations, 172 

pneumococcal conjugate vaccines (PCV). see 


vaccine); 13vPCV (13-valent pneumococcal 

conjugate vaccine) 

pneumococcal disease, 317–337 


(AEFI), 335–336 


catch-up vaccination for children, 46, 49, 50, 

52–53, 57–58, 59–60, 63 









immunocompromising conditions with 

increased risk of, 326–327 

and Indigenous persons, 108, 110–111 




and preterm infants, 143–144 






336–337 

pneumococcal polysaccharide vaccine. 

see 23vPPV (23-valent pneumococcal 

polysaccharide vaccine) 

pneumonia. see Haemophilus influenzae type b 

(Hib); pneumococcal disease 

Pneumovax 23, 322, 449 

catch-up schedule, 59–60 




police, vaccination recommendations, 171 

poliomyelitis, 338–344, 348–350 


(AEFI), 343 


catch-up vaccination for children, 46, 49, 

50, 53 




handbook, 15 







dose, 46 


intervals, 50 



pre-vaccination testing, 348–349 






343–344 

virology, 338 

poliovirus, 338 

polymyxin, in vaccines, 19, 472, 486 

polysorbate, in vaccines, 19, 472, 485 

pork industry workers. see animals, persons 

working with 

positioning for vaccination 

children, 77–78 

infants, 75–76 

older children, adolescents and adults, 78 

post-exposure prophylaxis 


measles, 281 


post-herpetic neuralgia (PHN), 446 

post-vaccination procedures 


(AEFI), 85–97 


handbook, 9 

documentation of vaccination, 97 

immediate after-care, 85 

immunisation registers, 98–103 

poultry workers. see animals, persons working 

with 

precautions to vaccination, 5, 22, 28, 130, 477. 

see also under individual disease names 

pregnancy 


contact with persons who received live 

vaccines, 134, 142 

and diphtheria vaccination, 187






and immunosuppressive therapy, 142 

and influenza vaccination, 252, 256 


264–265 

and measles, 267 


and meningococcal vaccination, 291–292 

and mumps, 295 


and pertussis vaccination, 303–304, 308, 

309, 310–311 


and Q fever vaccination, 350–351 

and rabies vaccination, 370 


and rubella, 384, 395–396 

and rubella vaccination, 385, 391–392, 

392–393 




133–144, 135–141 

and varicella vaccination, 430–431, 432 

and yellow fever vaccination, 443, 445 

and zoster immunoglobulin, 435–436 


premature infants. see preterm infants 

preparation for vaccine administration, 65, 70 

preparation of vaccines, 66–67 

pre-school workers. see early childhood 

education and care workers 

preservatives, in vaccines, 484 

preterm infants, 34, 38, 143–144, 475 

Haemophilus influenzae type b (Hib), 51, 

144, 195 

hepatitis B, 51, 144, 219 


needle size, length and angle, 72 

pneumococcal disease, 43, 53, 143–144, 327 

rotavirus, 144, 378–379 

pre-vaccination procedures, 24–64 

anaphylaxis response kit, 24 

catch-up, 38–64 


handbook, 8 

effective cold chain, 24–25 

screening, 28–38 

valid consent, 25–28 

pre-vaccination screening, 28–38 

checklist, 30–31 

responses to relevant conditions or 

circumstances, 31 

Prevenar 13, 320 

catch-up schedule, 56, 57–58, 59–60 




Priorix, 68, 269–270, 297, 386 

dosage and administration, 124, 271, 298, 

387 


387 



Priorix-tetra, 269, 270, 297, 386–387, 425–426 


seroresponse assessment in study, 269 


387, 427 



437 

prisoners and staff. see correctional facility 

inmates; correctional facility staff 

procedures for vaccination, 24–103 

administration of vaccines, 65–84 



post-vaccination, 85–103 

pre-vaccination, 24–64 

product information for vaccines. see vaccine 

product information 

prone position, 75–76, 78 

ProQuad, 68, 270, 297, 387, 425–426 


(AEFI), 279, 434 

seroresponse assessment in study, 269 


387, 427 

vaccine components, 469, 471–472 


437 

public health management, 5, 8. see also under 

individual disease names 

purified chick embryo cell vaccine (PCECV), 

69, 71, 133, 355, 356, 358, 363, 370 


Q 

Q fever, 345–352 


(AEFI), 351–352 

Australian Q Fever Register, 102 



handbook, 15 




INDEX 517 

INDEX








skin test, 68–69 


vaccine, 347 


Q fever fatigue syndrome (QFS), 345, 351 

Quadracel, 184, 306, 340, 399 



315, 344, 406 

quadrivalent meningococcal conjugate 

vaccines (4vMenCV), 14, 69, 120, 153, 157, 

171, 285–286. see also meningococcal disease 


(AEFI), 292 




293–294 

quadrivalent meningococcal polysaccharide 

vaccines (4vMenPV), 14, 20, 68, 71, 120, 285, 

287, 290–291. see also meningococcal disease 


(AEFI), 292 



and pregnancy, 136 



Queensland 

ACIR reporting, 98 





cholera, 176 




hepatitis A, 105, 107, 199, 201, 203, 204 

HPV reporting, 101 



pneumococcal disease, 15, 52, 57, 57–58, 

105, 108, 110, 318, 324 

Q fever, 346 


Vaccine Information and Vaccine 

Administration System (VIVAS), 102–103 



Q-Vax, 132, 347 



Q-Vax Skin Test, 347 


skin test process and interpretation, 

348–350 


R 


Australian bat lyssavirus), 68–69, 353–371 


(AEFI), 370 

booster algorithm, 369 








exposure categories, 360 


post-exposure prophylaxis, 357, 360–368, 

366, 367 

pre-exposure prophylaxis, 356–357, 359–360 


rabies immunoglobulin, 355–356 





vaccines, 355 

virology, 353 

rabies immunoglobulin (HRIG), 357, 457, 

460. see also rabies and other lyssaviruses 

(including Australian bat lyssavirus) 

Rabipur Inactivated Rabies Virus Vaccine, 71, 

133, 355. see also purified chick embryo cell 

vaccine (PCECV) 


radiation therapy, persons receiving. see 


rash 


zoster (herpes zoster), 446 


recommendation changes in the 10th edition of 

the handbook, 8–17 

reconstitution of vaccines, 66–67 

refugees. see migrants to Australia 

registers for immunisation, 85–97 

regurgitation of a vaccine, 73, 376, 383 

renal impaired patients, hepatitis B vaccination, 

222 

respiratory papillomatosis, 234

espiratory syncytial virus monoclonal 

antibody, 457, 462 

Reye syndrome, and varicella vaccination, 438 

rheumatoid arthritis, vaccination 


risks and benefits of vaccines, 27 

Rotarix, 374–375 


(AEFI), 381–382 




RotaShield, 374–375 

RotaTeq, 374–375 


(AEFI), 381–382 






rotavirus, 372–383 


(AEFI), 381–382 


children, 53 


handbook, 16 




dosage and administration, 47, 49, 50, 376 








and recipients of normal human 

immunoglobulin and other blood 

products, 166 






virology, 372 



(AEFI), 394 








and Indigenous persons, 111 



pregnancy and breastfeeding, 391–392, 

392–393, 395–396 



serological testing for immunity, 390–391, 

395 





virology, 384 

and women of child-baring age, 390, 391 

Rubivirus, 384. see also rubella 

S 

safety of vaccines, 21–23 

salicylate therapy. see aspirin therapy 

Salmonella enterica subspecies enterica serovar 

Typhi, 416. see also typhoid 

Saudi Arabia. see also Middle East, pilgrimage 

to Mecca (Hajj and Umra), 116, 120, 129, 290 

school teachers, vaccination recommendations, 

170 

school-based vaccination programs, 28 

screening. see pre-vaccination screening 

seizures, persons with family history, and 


septic arthritis, 191 

septicaemia, 283. see also meningococcal disease 





mumps, 300 



rubella, 390–391, 395 


zoster (herpes zoster), 452–453 

serum, in vaccines, 469, 486 

severe combined immunodeficiency, 16, 379 

severe dehydrating gastroenteritis, 372. see also 

rotavirus 

sex industry workers, 11, 175 


hepatitis B, 223, 224, 225 

shearers. see animals, persons working with 

shingles. see zoster (herpes zoster) 

Shingles Prevention Study, 447–448 

short gut syndrome, and rotavirus vaccination, 

380 

sickle cell disease, and pneumococcal disease, 

326–327 

INDEX 519 

INDEX

simultaneous injections, 9, 84 

sinusitis, 317 

skin cleaning for vaccination, 70 

skin disease, and tuberculosis vaccination, 414 

skin penetration procedures, vaccination 

recommendations, 172, 209, 210, 223 

skin test. see Q-Vax Skin Test; tuberculin skin 

test 

smallpox, 1, 7, 104, 171, 482 

smokers. see tobacco smoking 

sodium borate, in vaccines, 470 

solid organ transplant (SOT) recipients 





151–154 

sorbitol, in vaccines, 19, 472, 485 

South Australia 








hepatitis A, 105, 107, 199, 203, 204 

online ‘catch-up calculator,’ 39 

pneumococcal disease, 52, 57, 57–58, 105, 

108, 318, 324 


special risk groups, 9–11, 104–175. see also under 

risk group names 

Aboriginal and Torres Strait Islander 

people, 35, 104–112 

adverse event following immunisation, 

130–133 

anaesthesia or surgery, 36, 168 

bleeding disorders, 168 

blood product recipients, 33, 166–167 

correctional facility inmates, 174 

drugs, persons who inject, 175 

men who have sex with men, 174 

migrants to Australia, 173–174 

normal human immunoglobulin (NHIG) 

recipients, 166–167 

occupational risks, 169–173 

sex industry workers, 175 

travellers, 127–128 

spica casts, injection sites, 74 

splenectomy. see asplenia, persons with 

Stamaril, 440 


(AEFI), 444 


and egg protein, 132 




status of vaccination. see vaccination status and 

history 

steroids, and zoster vaccination, 453 

straddle position, 77–78 

Streptococcus pneumoniae, 108, 155, 317. see also 


subcutaneous (SC) injection, 68–69, 72, 82 

sucrose, in vaccines, 19, 485 

sudden infant death syndrome (SIDS), 94, 143 


surgery, vaccination recommendations before 

or after, 168 

Synagis, 457, 462 

Synflorix, 320 


systemic lupus erythematosus, vaccination 


T 

Tasmania 


(AEFI) notification, 96 






pneumococcal disease, 52, 56 

tattooists. see skin penetration procedures 

tetanus, 397–407 


(AEFI), 405 












tetanus-prone wounds, 402–404 





405–407 

tetanus immunoglobulin (TIG), 403–404 


intramuscular use, 462–463 

intravenous use, 463 

Tetanus Immunoglobulin-VF, 405, 463. see also 

tetanus immunoglobulin (TIG)

Therapeutic Goods Administration (TGA), 5, 7, 

18, 94, 461, 482, 486 



direct reporting to, 96–97 


thimerosal. see thiomersal, in vaccines 

thiomersal, in vaccines, 19, 347, 469, 484 

thrombocytopenia, 493 


and passive immunisation, 464 

and rubella vaccination, 384, 394 

and varicella vaccination, 423, 434 

thymus disorders, and yellow fever 


tick-borne encephalitis, and travellers, 121 

tobacco smoking, and pneumococcal disease, 

110, 327, 331 

Torres Strait Islanders. see Aboriginal and 

Torres Strait Islander people 

Torres Strait Islands. see also Queensland, and 

Japanese encephalitis vaccination, 111, 172, 

264 

transplants. see haematopoietic stem cell 

transplant (HSCT) recipients; solid organ 

transplant (SOT) recipients 

transport, storage and handling of vaccines, 7, 

24–25. see also under individual disease names 

travellers. see also Africa; Americas; Asia; 

Europe; Middle East; Oceania; Saudi Arabia 

children – lower age limits for vaccines, 

127–128 

cholera, 119 

common infections, 113–114 




hepatitis B, 117–118, 224 

immunocompromised persons, 147 

influenza, 118, 256 

Japanese encephalitis, 119, 263–264 

measles, 274 



vaccine, 118 

online information sources on health risks 

for, 128–129 


pilgrimage to Mecca (Hajj and Umra), 16, 

120, 129, 290 

pneumococcal disease, 118 

poliomyelitis, 118, 342 

pre-travel information to acquire, 114–117 

rabies, 120, 358 

routinely recommended vaccines, 117–118 

special risk groups, 127–128 

tetanus, 117 

tick-borne encephalitis vaccination, 121 


typhoid, 122, 417, 419–420 


vaccine documentation, 116–117 

vaccines based on itinerary, 119–126 

vaccines required by International Health 

Regulations, 116 

yellow fever, 122, 440, 441–442 

Tripacel, 184, 306, 400 


315, 406 

tuberculin skin test, 116, 121, 410, 413 

and measles-mumps-rubella (MMR) 


tuberculosis (TB), 408–415 


(AEFI), 414 


BCG vaccination procedures, 411 


handbook, 16 





and Indigenous neonates, 106, 412 

precautions, 121, 414 







Twinrix (720/20), 200, 212 




vaccination schedules, 215, 217 

vaccination schedules, accelerated, 216 

Twinrix Junior (360/10), 200, 211–212 



recommended doses and schedules, 202 


Typherix, 417 



Typhim Vi, 417 




typhoid, 416–422 





INDEX 521 

INDEX





pregnancy and breastfeeding, 137, 139, 421 








V 

vaccination, commonly asked questions, 

473–488 

vaccination contraindications. see 

contraindications to vaccination 

vaccination documentation. see documentation 

of vaccination 

vaccination procedures. see procedures for 

vaccination 

vaccination recommendations. see under 

individual disease names 

vaccination status and history, 39–40 

vaccine administration. see administration of 

vaccines 

vaccine availability in Australia, 498–499 

vaccine components, commonly asked 

questions about, 484–486 

vaccine effectiveness, 20–21 

vaccine efficacy, 20–21 

vaccine failure, 20–21 

Vaccine Information and Vaccine 

Administration System (VIVAS), 102–103 

vaccine preparation. see preparation of vaccines 

vaccine product information, 5, 6, 19. see also 

under individual disease names, variations from 

product information 

vaccine safety, 21–23. see also adverse events 

following immunisation (AEFI) 

commonly asked questions about, 481–483 

vaccine side effects. see adverse events 

following immunisation (AEFI) 

vaccine-preventable diseases, 175–455. see also 

under individual disease names 



cholera, 11, 176–181 

diphtheria, 11–12, 182–190 

Haemophilus influenzae type b (Hib), 12, 

191–197 

hepatitis A, 12, 198–207 

hepatitis B, 12, 208–230 

human papillomavirus (HPV), 13, 231–242 

influenza, 13, 243–258 

Japanese encephalitis, 13, 259–266 


measles, 13–14, 267–282 

meningococcal disease, 14, 283–294 

mumps, 13–14, 295–301 

pertussis, 11–12, 302–316 

pneumococcal disease, 14–15, 317–337 

poliomyelitis, 15, 338–344 

Q fever, 15, 345–352 


Australian bat lyssavirus), 15–16, 353–371 

rotavirus, 16, 372–383 

rubella, 13–14, 384–396 

tetanus, 11–12, 397–407 

tuberculosis, 16, 408–415 

typhoid, 416–422 

varicella, 13–14, 423–438 

yellow fever, 16, 439–445 

zoster (herpes zoster), 16, 446–455 

vaginal cancer, 233 

valid consent. see consent 

valid dose. see dosage 

Vaqta Adult formulation, 200 



Vaqta Paediatric/Adolescent formulation, 200 






(AEFI), 433–435 

catch-up vaccination, 52, 63–64 



and children, 427–428 






higher risk groups, 430 




dose, 47 

post-exposure vaccination, 429–430, 437 


pregnancy and breastfeeding, 140, 430–431, 

432 




transport, storage and handling, 426–427 


vaccines, 68–69, 424–426 


437–438 

virology, 423

varicella-zoster immunoglobulin, 457 

varicella-zoster virus (VZV), 423, 446. see also 

varicella; zoster (herpes zoster) 

Varilrix, 48, 425 



vaccine components, 469, 469–472, 471 


Varivax Refrigerated, 425 





438 

vasovagal episode, 87–88 

vastus lateralis injection site, 73, 75, 78, 79–80, 

474 

Vaxigrip, 247 


Vaxigrip Junior, 247 

ventrogluteal injection site, 73, 74, 76, 78, 80–81, 

83, 84, 474 

veterinarians. see animals, persons working 

with 

Vibrio cholerae, 119, 176. see also cholera 

Victoria 








pneumococcal disease, 52, 56, 322 

pneumococcal vaccination, 52, 56 

Victorian Cytology Service, 101 

viral haemorrhagic fever. see yellow fever 

Vivaxim, 200, 417 

dosage and administration, 125–126, 202, 

419 

recommended doses and schedules, 202 

Vivotif Oral, 417–418 




vulval cancer, 233 

W 

Western Australia 








hepatitis A, 105, 107, 199, 203, 204 

hepatitis A vaccine recommendations for 

Indigenous persons, 203 

influenza, 92 

pneumococcal disease, 15, 52, 57, 105, 108, 

318, 324 

pneumococcal vaccination, 57–58 


whooping cough. see pertussis 

wildlife workers. see animals, persons working 

with 

women. see also breastfeeding; human 

papillomavirus, female vaccination; 

pregnancy 

planning pregnancy, pregnant or 

breastfeeding, 133–142 

rubella vaccination for women of childbaring 

age, 390, 391 

World Health Organization Global Advisory 

Committee on Vaccine Safety, 228 

World Health Organization (WHO) 

global elimination of measles, 268 

Global Polio Eradication Initiative, 338 

immunisation schedules for other 

countries, 173 

influenza pandemic, 245–246 

rabies vaccine recommendations, 358, 363, 

367 


serological testing for immunity to rubella, 

391 

and tuberculosis, 408 

yellow fever vaccination requirements, 442 

wounds 

management after rabies or lyssavirus 

exposure, 357, 361, 366, 367 

tetanus prophylaxis for, 403–404 

tetanus-prone wounds, 402–404 

Y 

yeast, in vaccines, 472 

yellow fever, 68–69 


(AEFI), 444 


handbook, 16 










pregnancy and breastfeeding, 139, 443, 445 



INDEX 523 

INDEX



vaccine, 440 


virology, 439 

yellow fever vaccine-associated viscerotropic 

disease, 444, 445 

Z 

Zagreb, 363 

zoo workers. see animals, persons working 

with 

Zostavax, 323–324, 447–449 


(AEFI), 454 






455 

zoster (herpes zoster), 446–455 


(AEFI), 454 



handbook, 16 



449–450, 453 






and recipients of normal human 

immunoglobulin and other blood 

products, 166 

recommendations, 147, 159, 450–453 

serological testing for immunity, 452–453 


vaccine, 68–69, 447–449 


virology, 446 

zoster immunoglobulin (ZIG), 460. see also 

Zoster Immunoglobulin-VF (human) 

Zoster Immunoglobulin-VF (human), 435–437 



INDEX 525 

INDEX

The Australian Immunisation Handbook 10th Edition 2013

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